Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Dialysis-dependent Chronic Kidney Disease (DD-CKD)
Phase 3, Randomized, Open-Label, Active-Controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-Dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE-CONVERSION)
2 other identifiers
interventional
3,554
18 countries
278
Brief Summary
A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with dialysis-dependent chronic kidney disease (DD-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 Aug 2016
Typical duration for phase_3
278 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
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 2, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedResults Posted
Study results publicly available
June 28, 2022
CompletedJune 28, 2022
June 1, 2022
3.5 years
September 2, 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 hemoglobin concentration (\<10.0 versus ≥10.0 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. INNOVATE MACE results and analysis, by design, was performed on pooled data from studies AKB-6548-CI-0016 (NCT02865850) and AKB-6548-CI-0017 (NCT02892149). Results and statistical analysis from study AKB-6548-CI-0017 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-0016 and AKB-6548-CI-0017 has been reported under section "Statistical Analysis 2" of this outcome measure.
Up to 170 weeks
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 170 weeks
Median Time to First Cardiovascular MACE
Up to 170 weeks
Median Time to First Cardiovascular Death
Up to 170 weeks
Median Time to First All-cause Mortality
Up to 170 weeks
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. For participants already on Darbepoetin alfa, the initial dosing regimen in the study was based on the prior dosing regimen.
Eligibility Criteria
You may qualify if:
- ≥18 years of age
- Receiving chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease for at least 12 weeks prior to Screening
- Currently maintained on erythropoiesis-stimulating agent therapy, with a dose received within 6 weeks prior to or during Screening
- Mean Screening hemoglobin between 8.0 and 11.0 grams per deciliter (g/dL) (inclusive) in the US and between 9.0 and 12.0 g/dL (inclusive) outside of the US
- 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 chronic kidney disease or participants with active bleeding or recent blood loss
- Uncontrolled hypertension
- Red blood cell transfusion within 8 weeks prior to randomization
- Anticipated to recover adequate kidney function to no longer require dialysis
- 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 Vadadustat, Darbepoetin alfa, or any of their excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (278)
Research Site
Huntsville, Alabama, 35805, United States
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Mesa, Arizona, 85210, United States
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Pine Bluff, Arkansas, 71603, United States
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Anaheim, California, 92801, United States
Research Site #1
Bakersfield, California, 93309, United States
Research Site #2
Bakersfield, California, 93309, United States
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Canyon Country, California, 91387, United States
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Chula Vista, California, 91910, United States
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Downey, California, 90240, United States
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El Centro, California, 92243, United States
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Escondido, California, 92025, United States
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Fairfield, California, 94534, United States
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Glendale, California, 91206, United States
Research Site #1
Granada Hills, California, 91344, United States
Research Site #2
Granada Hills, California, 91344, United States
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La Habra, California, 90631, United States
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La Mesa, California, 91942, United States
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Lakewood, California, 90712-2512, United States
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Long Beach, California, 90807, United States
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Long Beach, California, 90813, United States
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Long Beach, California, 92886, United States
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Los Angeles, California, 90022, United States
Research Site #1
Montebello, California, 90640, United States
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Monterey Park, California, 91754, United States
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Newhall, California, 91321, United States
Research Site #1
Northridge, California, 91324, United States
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Northridge, California, 91324, United States
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Riverside, California, 92503, 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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San Diego, California, 92111, United States
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San Diego, California, 92115, United States
Research Site #1
San Dimas, California, 91773, United States
Research Site #2
San Dimas, California, 91773, United States
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Simi Valley, California, 93065, United States
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Tarzana, California, 91356, United States
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Whittier, California, 90603, United States
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Whittier, California, 90606, 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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Stamford, Connecticut, 06902, United States
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Bradenton, Florida, 34209, 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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Hollywood, Florida, 33024, United States
Research Site #1
Lauderdale Lakes, Florida, 33313, United States
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Miami, Florida, 33125, United States
AMPM Research Clinic
Miami, Florida, 33145, United States
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Miami, Florida, 33150, United States
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Miami, Florida, 33173, United States
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Miami Beach, Florida, 33140, United States
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Ocala, Florida, 34471, United States
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Pembroke Pines, Florida, 33026, United States
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Tampa, Florida, 33614, United States
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Winter Park, Florida, 32789, United States
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Augusta, Georgia, 30904, United States
Research Site #1
Columbus, Georgia, 31904, United States
Research Site #2
Columbus, Georgia, 31904, United States
Research Site #1
Lawrenceville, Georgia, 30046, United States
Research Site #2
Lawrenceville, Georgia, 30046, United States
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Roswell, Georgia, 30076, United States
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Statesboro, Georgia, 30458, United States
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Meridian, Idaho, 83642, United States
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Fort Wayne, Indiana, 46804, United States
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Merrillville, Indiana, 46410, United States
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Monroe, Louisiana, 71201, United States
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Shreveport, Louisiana, 71101, United States
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Takoma Park, Maryland, 20912, United States
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Springfield, Massachusetts, 01107, United States
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Detroit, Michigan, 48202, United States
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Pontiac, Michigan, 48341, United States
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Port Huron, Michigan, 91344, United States
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Roseville, Michigan, 48066, United States
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Columbus, Mississippi, 39705, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63136, United States
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Albuquerque, New Mexico, 87109, United States
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Gallup, New Mexico, 87301, United States
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Santa Fe, New Mexico, 87505, United States
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Astoria, New York, 11102, United States
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Flushing, New York, 11355, United States
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Great Neck, New York, 11021, United States
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New York, New York, 10010, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10461, United States
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Yonkers, New York, 10710, United States
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Asheville, North Carolina, 28801, United States
Research Site #1
Charlotte, North Carolina, 28204, United States
Research Site #2
Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27704, United States
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Greenville, North Carolina, 27834, United States
Research Site #1
New Bern, North Carolina, 28562, United States
Research Site #2
New Bern, North Carolina, 28562, United States
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Winston-Salem, North Carolina, 27103, United States
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Philadelphia, Pennsylvania, 19106, United States
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Providence, Rhode Island, 02903, United States
Research Site #1
Chattanooga, Tennessee, 37408, United States
Research Site #2
Chattanooga, Tennessee, 37408, United States
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Knoxville, Tennessee, 37923, United States
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Nashville, Tennessee, 37205, United States
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Arlington, Texas, 76015, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78751, United States
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Austin, Texas, 78758, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75235, United States
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Duncanville, Texas, 75137, United States
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El Paso, Texas, 77429, United States
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Greenville, Texas, 75402, United States
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Houston, Texas, 77030, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77099, United States
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McAllen, Texas, 78503, United States
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San Antonio, Texas, 78202, 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, 78221, United States
Research Site #2
San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78251, United States
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St. George, Utah, 84790, United States
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South Burlington, Vermont, 05403, United States
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Hampton, Virginia, 23666, United States
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Manassas, Virginia, 20110, United States
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Norfolk, Virginia, 23502, United States
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Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH, Argentina
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Junín, Buenos Aires, 6000, Argentina
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Pergamino, Buenos Aires, B2700CPM, Argentina
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Sarandí, Buenos Aires, B1872EEA, Argentina
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Corrientes, 3400, Argentina
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Córdoba, 5000, Argentina
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Córdoba, X5000EVQ, Argentina
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Salta, A4400AXO, Argentina
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San Luis, 5700, Argentina
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Liverpool, New South Wales, 2170, Australia
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New Lambton Heights, New South Wales, 2305, Australia
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Wahroonga, New South Wales, 2076, Australia
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Cairns, Queensland, 4870, Australia
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Launceston, Tasmania, 7250, Australia
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Box Hill, Victoria, 3128, Australia
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Fitzroy, Victoria, 3065, Australia
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Nedlands, Western Australia, 6009, Australia
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Fortaleza, Ceará, 60430-370, Brazil
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Vitória, Espírito 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, 30130-100, Brazil
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Belo Horizonte, Minas Gerais, 30150-221, Brazil
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Juiz de Fora, Minas Gerais, 36025-330, Brazil
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Juiz de Fora, Minas Gerais, 36036-330, Brazil
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Curitiba, Paraná, 80010-030, Brazil
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Maringá, Paraná, 87060-040, Brazil
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Canoas, Rio Grande do Sul, 92425-900, 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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Criciúma, Santa Catarina, 88801-250, Brazil
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Joinville, Santa Catarina, 89202-050, Brazil
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Santo André, São Paulo, 09080-110, Brazil
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Santo André, São Paulo, 09090-790, Brazil
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São Bernardo do Campo, São Paulo, 09715-090, Brazil
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São José do Rio Preto, São Paulo, 15015-200, Brazil
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São Paulo, São Paulo, 01232-010, Brazil
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São Paulo, São Paulo, 04039-000, Brazil
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São Paulo, São Paulo, 05403-000, Brazil
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Byala, 7100, Bulgaria
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Cherven Bryag, 5980, Bulgaria
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Dobrich, 9300, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Haskovo, 6300, Bulgaria
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Plovdiv, 4002, Bulgaria
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Rousse, 7002, Bulgaria
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Shumen, 9700, Bulgaria
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Silistra, 7500, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1750, Bulgaria
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Varna, 9002, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Vidin, 3700, Bulgaria
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Vratsa, 3000, Bulgaria
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Halifax, Nova Scotia, B3H 2Y0, Canada
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Sydney, Nova Scotia, B1P 1P3, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Oshawa, Ontario, L1H 1B9, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2X 3J4, Canada
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Marseille, Bouches-du-Rhône, 13005, France
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Bordeaux, Gironde, 33300, France
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Reims, Marne, 51092, France
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Saint-Priest-En-Jarez, Pays de la Loire Region, 42055, France
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Paris, 75015, France
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Paris, 75020, France
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Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany
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Rostock, Mecklenburg-Vorpommern, 18057, Germany
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Düsseldorf, North Rhine-Westphalia, 40210, Germany
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Berlin, 10117, Germany
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Ashkelon, 78278, Israel
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Haifa, 3109601, Israel
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Haifa, 34362, Israel
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Jerusalem, 91031, Israel
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Kfar Saba, 4428164, Israel
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Rishon LeZiyyon, 75141, Israel
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Bari, 70124, Italy
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Genova, 16132, Italy
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Lecco, 23900, Italy
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Pavia, 27100, Italy
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Roma, 168, Italy
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Siena, 53100, Italy
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Pachuca, Hidalgo, 42070, Mexico
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Zapopan, Jalisco, 45030, Mexico
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Morelia, Michoacán, 58260, Mexico
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Culiacán, Sinaloa, 80230, Mexico
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Biała Podlaska, 21-500, Poland
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Golub-Dobrzyń, 87-400, Poland
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Kołobrzeg, 78-100, Poland
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Lodz, 90-153, Poland
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Lodz, 92-213, Poland
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Lodz, 93-338, Poland
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Warsaw, 04-749, Poland
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Beja, 7800-309, Portugal
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Leiria, 2400-441, Portugal
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Loures, 2674-514, Portugal
Research Site #2
Kemerovo, 650066, Russia
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Moscow, 123182, Russia
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Moscow, 125466, Russia
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Nizhny Novgorod, 603001, Russia
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Nizhny Novgorod, 603076, Russia
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Novorossiysk, 353915, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197110, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 199004, Russia
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Yekaterinburg, 620102, Russia
Research Site #1
Belgrade, 11000, Serbia
Research Site #2
Belgrade, 11000, Serbia
Research Site #3
Belgrade, 11000, Serbia
Research Site #4
Belgrade, 11000, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Zaječar, 19000, Serbia
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Chuncheon, Gangwon-do, 200-702, South Korea
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Bucheon-si, Gyeonggi-do, 14647, South Korea
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Goyang-si, Gyeonggi-do, 10380, South Korea
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Goyang-si, Gyeonggi-do, 10444, South Korea
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Guri-si, Gyeonggi-do, 11923, South Korea
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Seongnam-si, Gyeonggi-do, 13496, South Korea
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Suwon, Gyeonggi-do, 16247, South Korea
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Busan, 47392, South Korea
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Busan, 49201, South Korea
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Seoul, 2841, South Korea
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Seoul, 3080, South Korea
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Seoul, 6351, South Korea
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Seoul, 6591, South Korea
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Seoul, 7345, South Korea
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Brovary, 7400, Ukraine
Research Site #1
Cherkassy, 18009, Ukraine
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Dnipro, 49005, Ukraine
Research Site
Ivano-Frankivsk, 76008, Ukraine
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Kharkiv, 61037, Ukraine
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Kyiv, 2125, Ukraine
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Mykolaiv, 54058, Ukraine
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Ternopil, 46002, Ukraine
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Uzhhorod, 88018, Ukraine
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Vinnytsia, 21018, Ukraine
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Zaporizhzhia, 69600, Ukraine
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Zhytomyr, 10002, Ukraine
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Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
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London, Greater London, SE5 9RS, United Kingdom
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Stevenage, Hertfordshire, SG1 4AB, United Kingdom
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Kettering, Leicestershire, NN16 8DB, United Kingdom
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Doncaster, South Yorkshire, DN2 5LT, United Kingdom
Related Publications (4)
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: 40359056DERIVEDSarnak MJ, Agarwal R, Boudville N, Chowdhury PCP, Eckardt KU, Gonzalez CR, Kooienga LA, Koury MJ, Ntoso KA, Luo W, Parfrey PS, Vargo DL, Winkelmayer WC, Zhang Z, Chertow GM. Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis. Nephrol Dial Transplant. 2023 Sep 29;38(10):2358-2367. doi: 10.1093/ndt/gfad074.
PMID: 37096396DERIVEDNatale 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: 36005278DERIVEDEckardt KU, Agarwal R, Aswad A, Awad A, Block GA, Bacci MR, Farag YMK, Fishbane S, Hubert H, Jardine A, Khawaja Z, Koury MJ, Maroni BJ, Matsushita K, McCullough PA, Lewis EF, Luo W, Parfrey PS, Pergola P, Sarnak MJ, Spinowitz B, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Zwiech R, Chertow GM. Safety and Efficacy of Vadadustat for Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Apr 29;384(17):1601-1612. doi: 10.1056/NEJMoa2025956.
PMID: 33913638DERIVED
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
September 2, 2016
First Posted
September 8, 2016
Study Start
August 1, 2016
Primary Completion
January 16, 2020
Study Completion
March 30, 2020
Last Updated
June 28, 2022
Results First Posted
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share