Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease
Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Correction of Anemia in Subjects With Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CORRECTION)
2 other identifiers
interventional
1,751
20 countries
439
Brief Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2015
Longer than P75 for phase_3
439 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedResults Posted
Study results publicly available
June 27, 2022
CompletedJune 27, 2022
June 1, 2022
4.5 years
January 4, 2016
April 25, 2022
June 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Hemoglobin (Hb) to the Average Over the Primary Efficacy Period (Weeks 24 to 36)
The Baseline average was calculated as the average of the Hb values obtained at the screening visit closest to the date of randomization and the randomization visit. The average for the Primary Efficacy Period was calculated as the average Hb value over Weeks 24 to 36. Analysis was conducted using an analysis of covariance (ANCOVA) model with multiple imputation for missing data with Baseline Hb concentration (\<9.5 versus ≥9.5 grams per deciliter \[g/dL\]), geographic region (United States \[US\] versus European Union \[EU\] versus Rest of World \[ROW\]), and New York Heart Association congestive heart failure (NYHA CHF) class (Class 0 \[no CHF\] or I versus II or III) as covariates.
Baseline; Weeks 24 to 36
Median Time to First Major Adverse Cardiovascular Event (MACE)
MACE was defined as all-cause mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. The primary safety outcome was positively adjudicated first MACE, which was defined as any death, Endpoint Adjudication Committee (EAC)-confirmed non-fatal MI, or EAC-confirmed non-fatal stroke occurring between the first dose date and each participant's last participation date. PROTECT MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0014 (NCT02648347) and AKB-6548-CI-0015 (NCT02680574). Results and statistical analysis from study AKB-6548-CI-0014 has been reported in below table and under section "Statistical Analysis 1". Results and statistical analysis of the pooled data from studies AKB-6548-CI-0014 and AKB-6548-CI-0015 has been reported under section "Statistical Analysis 2" of this outcome measure.
Up to Week 208
Secondary Outcomes (5)
Change From Baseline in Hb to the Average Over the Secondary Efficacy Period (Weeks 40 to 52)
Baseline; Weeks 40 to 52
Median Time to First MACE Plus Hospitalization for Heart Failure or Thromboembolic Event Excluding Vascular Access Thrombosis
Up to Week 208
Median Time to First Cardiovascular MACE
Up to Week 208
Median Time to First Cardiovascular Death
Up to Week 208
Median Time to First All-cause Mortality
Up to Week 208
Other Outcomes (10)
Exploratory - Proportion of Participants With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)
Weeks 24 to 36
Exploratory - Proportion of Time With Hb Values Within the Target Range During the Primary Evaluation Period (Weeks 24 to 36)
Weeks 24 to 36
Exploratory - Proportion of Time With Hb Values Within the Target Range During the Secondary Evaluation Period (Weeks 40 to 52)
Weeks 40 to 52
- +7 more other outcomes
Study Arms (2)
Vadadustat
EXPERIMENTALDarbepoetin alfa
ACTIVE COMPARATORInterventions
Oral dose administered once daily for ≥36 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Subcutaneous or intravenous dose administered for ≥36 weeks. Initial dose based on the current package insert for investigational sites in the United States (US), and the Summary of Product Characteristics for all other investigational sites (non-US) for adult participants with chronic kidney disease not on dialysis.
Eligibility Criteria
You may qualify if:
- ≥18 years of age
- Diagnosis of chronic kidney disease (CKD) with an estimated glomerular filtration rate ≤60 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) at Screening and not expected to start dialysis within 6 months of Screening
- Mean Screening hemoglobin \<10.0 grams per deciliter (g/dL)
- Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT) ≥20% during Screening
You may not qualify if:
- Anemia due to a cause other than CKD or participants with active bleeding or recent blood loss
- Red blood cell transfusion within 8 weeks prior to randomization.
- Any erythropoietic stimulating agent within 8 weeks prior to randomization
- Uncontrolled hypertension
- Severe heart failure at Screening (New York Heart Association Class IV)
- Acute coronary syndrome (hospitalization for unstable angina or myocardial infarction), surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity), surgical or percutaneous valvular replacement or repair, sustained ventricular tachycardia, hospitalization for heart failure, or stroke within 12 weeks prior to or during Screening
- Hypersensitivity to Darbepoetin or Vadadustat or to any of their excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (439)
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Huntsville, Alabama, 35805, United States
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Tuscumbia, Alabama, 35674, United States
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Glendale, Arizona, 85306, United States
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Mesa, Arizona, 85210, United States
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Phoenix, Arizona, 85027, United States
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Tucson, Arizona, 85718, United States
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Tucson, Arizona, 85724, United States
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Anaheim, California, 92801, United States
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Bakersfield, California, 93309, United States
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Chula Vista, California, 91910, United States
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Chula Vista, California, 91910, United States
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Fountain Valley, California, 92708, United States
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Fountain Valley, California, 92708, United States
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Glendale, California, 91206, United States
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Granada Hills, California, 91344, United States
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La Mesa, California, 91942, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90807, United States
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Long Beach, California, 92886, United States
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Los Angeles, California, 90020, United States
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Lynwood, California, 90262, United States
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Northridge, California, 91324, United States
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Northridge, California, 91324, United States
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Riverside, California, 92505, United States
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Roseville, California, 95661, United States
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Sacramento, California, 95825, United States
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Salinas, California, 93901, United States
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San Diego, California, 92103-6204, United States
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San Dimas, California, 91773, United States
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San Dimas, California, 91773, United States
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Santa Ana, California, 92704, United States
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Santa Monica, California, 90404, United States
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Sherman Oaks, California, 91403, United States
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Thousand Oaks, California, 91360, United States
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Upland, California, 91786, United States
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Whittier, California, 90603, United States
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Whittier, California, 90603, United States
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Arvada, Colorado, 80002, United States
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Denver, Colorado, 80230, United States
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Westminster, Colorado, 80031, United States
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New Haven, Connecticut, 06511, United States
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Stamford, Connecticut, 06902, United States
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Waterbury, Connecticut, 06708, United States
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Bradenton, Florida, 34209, United States
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Brandon, Florida, 33511, United States
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Cooper City, Florida, 33024, United States
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Coral Gables, Florida, 33134, United States
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Coral Gables, Florida, 33134, United States
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Coral Springs, Florida, 33065, United States
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Coral Springs, Florida, 33071, United States
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Doral, Florida, 33166, United States
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Fort Myers, Florida, 33901, United States
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Hialeah, Florida, 33010, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33018, United States
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Hollywood, Florida, 33024, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32204, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32216, United States
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Lake Worth, Florida, 33467, United States
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Lauderdale Lakes, Florida, 33313, United States
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Miami, Florida, 33122, United States
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Miami, Florida, 33125-4141, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33143, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33145, United States
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Miami, Florida, 33150, United States
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Miami, Florida, 33157, United States
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Miami, Florida, 33165, United States
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Miami, Florida, 33169, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33175, United States
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Miami Beach, Florida, 33140, United States
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Miami Lakes, Florida, 33014, United States
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Miami Lakes, Florida, 33016, United States
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Miami Springs, Florida, 33166, United States
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Pembroke Pines, Florida, 33026, United States
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Pompano Beach, Florida, 33060, United States
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Sweetwater, Florida, 33172, United States
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Tampa, Florida, 33604, United States
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Tampa, Florida, 33612, United States
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Tampa, Florida, 33614, United States
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Atlanta, Georgia, 30338, United States
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Atlanta, Georgia, 30342, United States
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Atlanta, Georgia, 30350, United States
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Augusta, Georgia, 30909, United States
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Augusta, Georgia, 30909, United States
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Columbus, Georgia, 31901, United States
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Columbus, Georgia, 31904, United States
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Columbus, Georgia, 31904, United States
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Lawrenceville, Georgia, 30046, United States
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Lawrenceville, Georgia, 30046, United States
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Macon, Georgia, 31217, United States
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Meridian, Idaho, 83642, United States
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Chicago, Illinois, 60637, United States
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Evanston, Illinois, 60201, United States
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McHenry, Illinois, 60050, United States
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Peoria, Illinois, 61603, United States
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Anderson, Indiana, 46011, United States
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Fort Wayne, Indiana, 46804, United States
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Jeffersonville, Indiana, 47130, United States
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Merrillville, Indiana, 46410, United States
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Merrillville, Indiana, 46410, United States
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Michigan City, Indiana, 46360, United States
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Monroe, Louisiana, 71201, United States
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New Orleans, Louisiana, 70115, United States
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Shreveport, Louisiana, 71101, United States
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Shreveport, Louisiana, 71103, United States
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Portland, Maine, 04102, United States
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Baltimore, Maryland, 21218, United States
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Greenbelt, Maryland, 20770, United States
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Takoma Park, Maryland, 20912, United States
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Methuen, Massachusetts, 01844, United States
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Plymouth, Massachusetts, 02360, United States
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Detroit, Michigan, 48202, United States
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Pontiac, Michigan, 48341, United States
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Roseville, Michigan, 48066, United States
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Saint Paul, Minnesota, 55102, United States
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Gulfport, Mississippi, 39501, United States
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Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64128, United States
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St Louis, Missouri, 63128, United States
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Butte, Montana, 59701, United States
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Lincoln, Nebraska, 68510, United States
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Omaha, Nebraska, 68124, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89106, United States
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Portsmouth, New Hampshire, 03801, United States
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Berlin, New Jersey, 08009, United States
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Voorhees Township, New Jersey, 08043, United States
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Albuquerque, New Mexico, 87106, United States
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Albuquerque, New Mexico, 87108, United States
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Albuquerque, New Mexico, 87109, United States
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Santa Fe, New Mexico, 87505, United States
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Flushing, New York, 11355, United States
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Laurelton, New York, 11413, United States
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New York, New York, 10010, United States
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The Bronx, New York, 10467, United States
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Asheville, North Carolina, 28801, United States
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Greenville, North Carolina, 27834, United States
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Greenville, North Carolina, 27834, United States
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Kinston, North Carolina, 28504, United States
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Morehead City, North Carolina, 28557, United States
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New Bern, North Carolina, 28560, United States
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Winston-Salem, North Carolina, 27103, United States
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Akron, Ohio, 44302, United States
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Cincinnati, Ohio, 45206, United States
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Dayton, Ohio, 45417, United States
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Marion, Ohio, 43302, United States
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Maumee, Ohio, 43537, United States
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Portland, Oregon, 97216, United States
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Philadelphia, Pennsylvania, 19140, United States
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East Providence, Rhode Island, 02915, United States
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Anderson, South Carolina, 29625, United States
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Orangeburg, South Carolina, 29118, United States
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West Columbia, South Carolina, 29169, United States
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Chattanooga, Tennessee, 37408, United States
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Knoxville, Tennessee, 37923, United States
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Memphis, Tennessee, 38104, United States
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Nashville, Tennessee, 37205, United States
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Arlington, Texas, 76015, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75390, United States
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DeSoto, Texas, 75115, United States
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El Paso, Texas, 79935, United States
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Fort Worth, Texas, 76104, United States
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Gonzales, Texas, 78629, United States
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Greenville, Texas, 75401, United States
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Greenville, Texas, 75402, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77040, United States
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Lewisville, Texas, 75057, United States
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McAllen, Texas, 78503, United States
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McAllen, Texas, 78503, United States
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McKinney, Texas, 75069, United States
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McKinney, Texas, 75071, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78207, United States
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San Antonio, Texas, 78212-4740, United States
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San Antonio, Texas, 78224, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78240-1501, United States
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Sherman, Texas, 75090, United States
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Victoria, Texas, 77901, United States
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Clinton, Utah, 84015, United States
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Salt Lake City, Utah, 84115, United States
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Alexandria, Virginia, 22304, United States
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Arlington, Virginia, 22207, United States
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Danville, Virginia, 24541, United States
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Hampton, Virginia, 23666, United States
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Lansdowne Town Center, Virginia, 20176, United States
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Newport News, Virginia, 23606, United States
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Norfolk, Virginia, 23507, United States
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Salem, Virginia, 24153, United States
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Woodbridge, Virginia, 22191, United States
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Tacoma, Washington, 98405, United States
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Wenatchee, Washington, 98801, United States
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Madison, Wisconsin, 53705, United States
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BahĂa Blanca, Buenos Aires, B8001HXM, Argentina
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JunĂn, Buenos Aires, 6000, Argentina
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JunĂn, Buenos Aires, B6000BHA, Argentina
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Mar del Plata, Buenos Aires, B7600FYK, Argentina
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Mar del Plata, Buenos Aires, B7600FZ, Argentina
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Pergamino, Buenos Aires, B2700CPM, Argentina
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Ramos MejĂa, Buenos Aires, B1704ETD, Argentina
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San Miguel, Buenos Aires, B1663CNJ, Argentina
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San NicolĂ¡s de los Arroyos, Buenos Aires, B2900DMH, Argentina
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SarandĂ, Buenos Aires, B1872EEA, Argentina
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Temperley, Buenos Aires, 1834, Argentina
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Godoy Cruz, Mendoza Province, 5501, Argentina
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Rosario, Santa Fe Province, S2000DIF, Argentina
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San Miguel de TucumĂ¡n, TucumĂ¡n Province, 4000, Argentina
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San Miguel de TucumĂ¡n, TucumĂ¡n Province, T4000AXL, Argentina
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San Miguel de TucumĂ¡n, TucumĂ¡n Province, T4000ICL, Argentina
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San Miguel de TucumĂ¡n, TucumĂ¡n Province, T4000, Argentina
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Ciudad Autonoma Buenos Aires, C1093AAS, Argentina
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Ciudad Autonoma Buenos Aires, C1430CKE, Argentina
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Corrientes, 3400, Argentina
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CĂ³rdoba, 5000, Argentina
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CĂ³rdoba, X5000AAW, Argentina
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CĂ³rdoba, X5000EVQ, Argentina
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CĂ³rdoba, X5020AAA, Argentina
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Salta, 4406, Argentina
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San Luis, 5700, Argentina
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Camperdown, New South Wales, 2050, Australia
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Liverpool, New South Wales, 2170, Australia
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Cairns, Queensland, 4870, Australia
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Gold Coast, Queensland, 9726, Australia
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Herston, Queensland, 4006, Australia
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Adelaide, South Australia, 5000, Australia
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Bedford Park, South Australia, 5042, Australia
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Box Hill, Victoria, 3128, Australia
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Nedlands, Western Australia, 6009, Australia
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Perth, Western Australia, 6000, Australia
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Fortaleza, CearĂ¡, 60115-282, Brazil
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Fortaleza, CearĂ¡, 60430-370, Brazil
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VitĂ³ria, EspĂrito Santo, 29055-450, Brazil
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Feira de Santana, Estado de Bahia, 44001-584, Brazil
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Itabuna, Estado de Bahia, 45600-625, Brazil
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Belo Horizonte, Minas Gerais, 30150-320, Brazil
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Juiz de Fora, Minas Gerais, 36036-330, Brazil
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Curitiba, ParanĂ¡, 80230-130, Brazil
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Curitiba, ParanĂ¡, 80810-040, Brazil
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Curitiba, ParanĂ¡, 80810-040, Brazil
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MaringĂ¡, ParanĂ¡, 87060-040, Brazil
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Rio de Janeiro, Rio Do Janeiro, 20551-030, Brazil
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Canoas, Rio Grande do Sul, 92425-900, Brazil
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Caxias do Sul, Rio Grande do Sul, 95010-005, Brazil
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Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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CriciĂºma, Santa Catarina, 88801-250, Brazil
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Joinville, Santa Catarina, 89202-050, Brazil
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Botucatu, SĂ£o Paulo, 18618-970, Brazil
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Campinas, SĂ£o Paulo, 13087-567, Brazil
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Santo AndrĂ©, SĂ£o Paulo, 09080-110, Brazil
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Santo AndrĂ©, SĂ£o Paulo, 09090-790, Brazil
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SĂ£o Bernardo do Campo, SĂ£o Paulo, 09715-090, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 01141-020, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 01406-200, Brazil
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SĂ£o Paulo, SĂ£o Paulo, 04039-000, Brazil
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Dobrich, 9300, Bulgaria
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Lom, 3600, Bulgaria
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Silistra, 7500, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 4700, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1784, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Stara Zagora, 6003, Bulgaria
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Varna, 9000, Bulgaria
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Varna, 9002, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Pontoise, Val d'Oise, 95300, France
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Baja, 6500, Hungary
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Baja, 6500, Hungary
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BalatonfĂ¼red, 8230, Hungary
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Budapest, 1076, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4032, Hungary
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HĂ³dmezÅ‘vĂ¡sĂ¡rhely, 6800, Hungary
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Kalocsa, 6300, Hungary
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KaposvĂ¡r, 7400, Hungary
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Kecskemét, 6000, Hungary
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Kistarcsa, 2143, Hungary
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NyĂregyhĂ¡za, 4400, Hungary
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PĂ©cs, 7623, Hungary
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Szeged, 6720, Hungary
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SzigetvĂ¡r, 7900, Hungary
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Ashkelon, 78278, Israel
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Haifa, 3109601, Israel
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Nahariya, 2210001, Israel
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Ramat Gan, 52363, Israel
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Rishon LeZiyyon, 75141, Israel
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Piedimonte Matese, Caserta, 81016, Italy
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San Giovanni Rotondo, Foggia, 71013, Italy
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Bari, 70124, Italy
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Bergamo, 24127, Italy
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Cremona, 26100, Italy
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Genova, 16132, Italy
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Lecco, 23900, Italy
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Milan, 20142, Italy
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Napoli, 80131, Italy
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Napoli, 80138, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Roma, 00168, Italy
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Siena, 53100, Italy
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Kota Bharu, Kelantan, 15586, Malaysia
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Kuantan, Pahang, 25100, Malaysia
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Acapulco de JuĂ¡rez, Guerrero, 39670, Mexico
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Pachuca, Hidalgo, 42070, Mexico
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Pachuca, Hidalgo, 42090, Mexico
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Guadalajara, Jalisco, 44130, Mexico
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Zapopan, Jalisco, 45116, Mexico
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Zapopan, Jalisco, 45200, Mexico
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Mexico City, Mexico City, 06100, Mexico
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Mexico City, Mexico City, 06700, Mexico
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Morelia, MichoacĂ¡n, 58260, Mexico
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Monterrey, Nuevo LeĂ³n, 64710, Mexico
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San Juan del RĂo, QuerĂ©taro, 76800, Mexico
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CuliacĂ¡n, Sinaloa, 80030, Mexico
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CuliacĂ¡n, Sinaloa, 80200, Mexico
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CuliacĂ¡n, Sinaloa, 80230, Mexico
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MazatlĂ¡n, Sinaloa, 82110, Mexico
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Chihuahua City, 31203, Mexico
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Chihuahua City, 31217, Mexico
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Durango, 34000, Mexico
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Veracruz, 91900, Mexico
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Hamilton, 3200, New Zealand
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New Plymouth, 4342, New Zealand
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Lodz, 90-153, Poland
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Lodz, 93-338, Poland
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Nowa SĂ³l, 67-100, Poland
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Warsaw, 04-749, Poland
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Wroclaw, 50-414, Poland
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Caguas, 00725, Puerto Rico
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Kazan', 420012, Russia
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Kemerovo, 650066, Russia
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Krasnoyarsk, 660062, Russia
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Moscow, 115516, Russia
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Nizhny Novgorod, 603076, Russia
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Novosibirsk, 630008, Russia
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Novosibirsk, 630054, Russia
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Novosibirsk, 630091, Russia
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Petrozavodsk, 185019, Russia
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Pushkin, 196603, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 199106, Russia
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Saint Petersburg, 199226, Russia
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Tomsk, 634050, Russia
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Tosno, 187000, Russia
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Yaroslavl, 150062, Russia
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Port Elizabeth, Eastern Cape, 6001, South Africa
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Bloemfontein, Free State, 9301, South Africa
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Winnie Mandela, Free State, 9400, South Africa
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Pretoria, Gauteng, 0002, South Africa
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Pretoria, Gauteng, 0002, South Africa
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Pretoria, Gauteng, 1692, South Africa
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Vereeniging, Gauteng, 1935, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Durban, KwaZulu-Natal, 4001, South Africa
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Durban, KwaZulu-Natal, 4092, South Africa
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Durban, KwaZulu-Natal, 4096, South Africa
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Durban, KwaZulu-Natal, 4320, South Africa
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Tongaat, KwaZulu-Natal, 4399, South Africa
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Cape Town, Western Cape, 7925, South Africa
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George, Western Cape, 6529, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Worcester, Western Cape, 6850, South Africa
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Bucheon-si, Gyeonggi-do, 14647, South Korea
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Guri-si, Gyeonggi-do, 11923, South Korea
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Busan, 47392, South Korea
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Busan, 49201, South Korea
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Daegu, 41944, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Elche, Alicante, 03293, Spain
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Torrevieja, Alicante, 03186, Spain
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Palma de Mallorca, Balearic Islands, 07120, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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MĂ¡laga, MĂ¡laga, 29010, Spain
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AlmerĂa, 04007, Spain
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AlmerĂa, 04009, Spain
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Badajoz, 06006, Spain
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Barcelona, 08003, Spain
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Madrid, 28041, Spain
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Seville, 41013, Spain
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Seville, 41071, Spain
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Valencia, 46014, Spain
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Valencia, 46026, Spain
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Dnipro, 49005, Ukraine
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Ivano-Frankivsk, 76008, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
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Kharkiv, 61037, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61103, Ukraine
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Kharkiv, 61157, Ukraine
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Kropyvnytskyi, 25006, Ukraine
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Kyiv, 02125, Ukraine
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Kyiv, 04050, Ukraine
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Lviv, 79010, Ukraine
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Mykolaiv, 54058, Ukraine
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Odesa, 65025, Ukraine
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Vinnytsia, 21001, Ukraine
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Zaporizhzhia, 69118, Ukraine
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Zaporizhzhia, 69600, Ukraine
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Zhytomyr, 10002, Ukraine
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Aberdeen, Grampian Region, AB25 2ZB, United Kingdom
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London, Greater London, E1 1BB, United Kingdom
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London, Greater London, SE5 9RS, United Kingdom
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Salford, Greater Manchester, M6 8HD, United Kingdom
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Stevenage, Hertfordshire, SG1 4AB, United Kingdom
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Leicester, Leicestershire, LE5 4PW, United Kingdom
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Doncaster, South Yorkshire, DN2 5LT, United Kingdom
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Sheffield, South Yorkshire, S5 7AU, United Kingdom
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Swansea, SA6 6NL, United Kingdom
Related Publications (3)
Chertow GM, Eckardt KU, Sarnak MJ, Winkelmayer WC, Agarwal R, Minga T, Luo W, Burke SK. Safety and Efficacy of Vadadustat for the Treatment of CKD-Related Anemia within and outside the United States. J Am Soc Nephrol. 2025 Oct 1;36(10):1984-1997. doi: 10.1681/ASN.0000000708. Epub 2025 May 13.
PMID: 40359056DERIVEDNatale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
PMID: 36005278DERIVEDChertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.
PMID: 33913637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Information Desk
- Organization
- Akebia Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Akebia Therapeutics Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Sponsor was blinded during the study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 7, 2016
Study Start
December 1, 2015
Primary Completion
June 4, 2020
Study Completion
July 31, 2020
Last Updated
June 27, 2022
Results First Posted
June 27, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share