Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Erythropoietin-stimulating Agents
2 other identifiers
interventional
2,964
33 countries
455
Brief Summary
The purpose of this multi-center event-driven study in participants with anemia associated with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2016
Typical duration for phase_3
455 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
First Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedStudy Start
First participant enrolled
September 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2020
CompletedResults Posted
Study results publicly available
December 3, 2021
CompletedDecember 3, 2021
November 1, 2021
4.1 years
August 22, 2016
November 5, 2021
November 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis
Time to MACE defined as the time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \[MI\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied by \[\*\] number of participants with at least 1 event) divided by \[/\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.
Up to 3.9 person-years for CV follow-up time period
Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52)
Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.
Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
Secondary Outcomes (34)
Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period: Superiority Analysis
Up to 3.9 person-years for CV follow-up time period
Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period
Up to 3.9 person-years for CV follow-up time period
Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period
Up to 3.9 person-years for CV follow-up time period
Mean Average Monthly On-treatment IV Iron Dose Per Participant
Day 1 to Week 52
Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period
Up to 3.9 person-years for vital status follow-up time period
- +29 more secondary outcomes
Study Arms (2)
Daprodustat
EXPERIMENTALParticipants will receive oral daprodustat once daily.
rhEPO
ACTIVE COMPARATORParticipants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).
Interventions
Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.
The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
Participants will receive supplemental iron therapy if ferritin is \<=100 ng/mL or TSAT is \<=20%. The investigator will choose the route of administration and dose of iron.
Eligibility Criteria
You may qualify if:
- Age: 18 to 99 years of age (inclusive).
- Erythropoietin-stimulating agents (ESAs): Use of any approved ESA for at least the 6 weeks prior to screening and between screening and randomization.
- Hgb concentration: On Week -8: Hgb 8 to 12 grams per deciliter (g/dL). On randomization (Day 1): Hgb 8 to 11 g/dL and receiving at least the minimum ESA dose. Hgb \>11 g/dL to 11.5 g/dL and receiving greater than the minimum ESA dose.
- Dialysis: On dialysis \>90 days prior to screening and continuing on the same mode of dialysis from screening (Week -8) through to randomization (Day 1).
- Frequency of Dialysis: Hemodialysis (HD) \>=2 times/week and peritoneal dialysis (PD) \>=5 times/week. Home hemodialysis \>=2 times/week.
- Compliance with placebo \[randomization (Day 1) only\]: \>=80% and \<=120% compliance with placebo during run-in period.
- Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
You may not qualify if:
- Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).
- Ferritin: \<=100 nanograms (ng)/milliliter (mL) (\<=100 micrograms/liter \[L\]) at screening.
- Transferrin saturation (TSAT) (screening only): \<=20%.
- Aplasias: History of bone marrow aplasia or pure red cell aplasia.
- Other causes of anemia: Untreated Pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.
- Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding \<=4 weeks prior to screening through to randomization (Day 1).
- MI or acute coronary syndrome: \<=4 weeks prior to screening through to randomization (Day 1).
- Stroke or transient ischemic attack: \<=4 weeks prior to screening through to randomization (Day 1).
- Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.
- Current uncontrolled hypertension: Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of recombinant human erythropoietin (rhEPO).
- Alanine transaminase (ALT): \>2x upper limit of normal (ULN) at screening.
- Bilirubin: \>1.5xULN at screening.
- Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
- Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example \[e.g.\] Bosniak Category II F, III or IV) \> 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated \>=4 weeks prior to screening.
- Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or epoetin alfa or darbepoetin alfa.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (462)
GSK Investigational Site
Huntsville, Alabama, 35805, United States
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Pine Bluff, Arkansas, 71603, United States
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Anaheim, California, 92801, United States
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Bakersfield, California, 93308, United States
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Bakersfield, California, 93309, United States
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Beverly Hills, California, 90211, United States
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Cerritos, California, 90703, United States
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Chula Vista, California, 91910, 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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Fountain Valley, California, 92708, United States
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Glendale, California, 91205, United States
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Granada Hills, California, 91344, United States
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Hacienda Heights, California, 91745, United States
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La Mesa, California, 91942, United States
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La Palma, California, 90623, United States
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Lakewood, California, 90712, United States
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Long Beach, California, 90806, 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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Los Angeles, California, 90022, United States
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Los Angeles, California, 90095, United States
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Lynwood, California, 60262, United States
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Montebello, California, 90640, United States
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Monterey Park, California, 91754, United States
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Moreno Valley, California, 92553, United States
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Norco, California, 92860, United States
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Northridge, California, 91324, United States
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Ontario, California, 91762, United States
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Riverside, California, 92501, United States
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Sacramento, California, 95825, United States
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San Diego, California, 92103, United States
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San Diego, California, 92111, United States
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San Luis Obispo, California, 93405, United States
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Santa Clarita, California, 91387, United States
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Simi Valley, California, 93065-091, United States
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Tarzana, California, 91356, United States
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Whittier, California, 90602, United States
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Whittier, California, 90603, United States
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Yorba Linda, California, 92886, United States
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Middlebury, Connecticut, 06762, United States
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Washington D.C., District of Columbia, 20037, United States
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Aventura, Florida, 33180, United States
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Coral Gables, Florida, 33134, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32224, United States
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Lauderdale Lakes, Florida, 33313, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33143, United States
GSK Investigational Site
Miami, Florida, 33150, United States
GSK Investigational Site
Miami, Florida, 33156, United States
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Miami Gardens, Florida, 33169, United States
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Ocala, Florida, 34471, United States
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Port Charlotte, Florida, 33952, United States
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Spring Hill, Florida, 34608, United States
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Winter Park, Florida, 32789, United States
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Augusta, Georgia, 30904, United States
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Augusta, Georgia, 30912, United States
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Columbus, Georgia, 31904, United States
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Meridian, Idaho, 83642, United States
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Crystal Lake, Illinois, 60014, 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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Michigan City, Indiana, 46360, United States
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Iowa City, Iowa, 52242, United States
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Louisville, Kentucky, 40202, United States
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Baton Rouge, Louisiana, 70808, United States
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Baton Rouge, Louisiana, 70836, United States
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Greenbelt, Maryland, 20770, United States
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Takoma Park, Maryland, 20912-6385, United States
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Kalamazoo, Michigan, 49007, United States
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Pontiac, Michigan, 48341, United States
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Roseville, Michigan, 48066, United States
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Gulfport, Mississippi, 39501, United States
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Tupelo, Mississippi, 38801, United States
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Florissant, Missouri, 63033, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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Las Vegas, Nevada, 89102, United States
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Las Vegas, Nevada, 89107, United States
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Portsmouth, New Hampshire, 3801, United States
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Gallup, New Mexico, 87301, United States
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Brooklyn, New York, 11203, United States
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Buffalo, New York, 14215, United States
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Flushing, New York, 11355, United States
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Mineola, New York, 11501, United States
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New York, New York, 10029, United States
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Ridgewood, New York, 11385, 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
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Clyde, North Carolina, 28721, United States
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Raleigh, North Carolina, 27609, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27517, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45206, United States
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Cincinnati, Ohio, 45220, United States
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Roseburg, Oregon, 97471, United States
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Bethlehem, Pennsylvania, 18017, United States
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Philadelphia, Pennsylvania, 19140, United States
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Providence, Rhode Island, 02903, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29425, United States
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Sumter, South Carolina, 29150, United States
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Cordova, Tennessee, 38018, United States
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Knoxville, Tennessee, 37923, United States
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Knoxville, Tennessee, 37924, United States
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Nashville, Tennessee, 37205, United States
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Beaumont, Texas, 77701, United States
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Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77099, United States
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Lufkin, Texas, 75904, United States
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San Antonio, Texas, 78207, United States
GSK Investigational Site
San Antonio, Texas, 78221, United States
GSK Investigational Site
San Antonio, Texas, 78251, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
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Alexandria, Virginia, 22304, United States
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Fairfax, Virginia, 22033, United States
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Hampton, Virginia, 23666, United States
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Salem, Virginia, 24153, United States
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Bluefield, West Virginia, 24701, United States
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Shorewood, Wisconsin, 53211, United States
GSK Investigational Site
Burzaco, Buenos Aires, B1852FZD, Argentina
GSK Investigational Site
Ciudad Evita, Buenos Aires, B1778IFA, Argentina
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Pergamino, Buenos Aires, B2700CPM, Argentina
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Pilar, Buenos Aires, 1629, Argentina
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Córdoba, Córdoba Province, X5016KEH, Argentina
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Buenos Aires, 1425, Argentina
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Buenos Aires, C1181ACH, Argentina
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Buenos Aires, CP1431FWO, Argentina
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Formosa, P3600LLD, Argentina
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Mendoza, M5500AFA, Argentina
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Morón, B1708DPO, Argentina
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San Miguel de Tucumán, T4000AHL, Argentina
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Concord, New South Wales, 2139, Australia
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Kingswood, New South Wales, 2750, Australia
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Kogarah, New South Wales, 2217, Australia
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Liverpool, New South Wales, 2170, Australia
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St Leonards, New South Wales, 2065, Australia
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Westmead, New South Wales, 2145, Australia
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Wollongong, New South Wales, 2500, Australia
GSK Investigational Site
Birtinya, Queensland, 4575, Australia
GSK Investigational Site
Herston, Queensland, 4006, Australia
GSK Investigational Site
Woolloongabba, Queensland, 4102, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Melbourne, Victoria, 3004, Australia
GSK Investigational Site
St Albans, Victoria, 3021, Australia
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Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Murdoch, 6150, Australia
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Graz, 8036, Austria
GSK Investigational Site
Sankt Pölten, 3100, Austria
GSK Investigational Site
Vienna, 1030, Austria
GSK Investigational Site
Vienna, A-1130, Austria
GSK Investigational Site
Baudour, 7331, Belgium
GSK Investigational Site
Bruges, 8310, Belgium
GSK Investigational Site
Brussels, 1020, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Hasselt, 3500, Belgium
GSK Investigational Site
Ieper, 8900, Belgium
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Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Roeselare, 8800, Belgium
GSK Investigational Site
Salvador, Estado de Bahia, 40415-065, Brazil
GSK Investigational Site
Curitiba, Paraná, 80440-020, Brazil
GSK Investigational Site
Curitiba, Paraná, CEP 80230-130, Brazil
GSK Investigational Site
Passo Fundo, Rio Grande do Sul, 99010-080, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Joinville, Santa Catarina, 89227-680, Brazil
GSK Investigational Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
GSK Investigational Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
GSK Investigational Site
Feira de Santana, 44001-584, Brazil
GSK Investigational Site
Porto Alegre, 90035-070, Brazil
GSK Investigational Site
Porto Alegre, 90035-903, Brazil
GSK Investigational Site
São Paulo, 01323-001, Brazil
GSK Investigational Site
São Paulo, 01323903, Brazil
GSK Investigational Site
São Paulo, 04005-000, Brazil
GSK Investigational Site
São Paulo, 04039-000, Brazil
GSK Investigational Site
São Paulo, 08270-070, Brazil
GSK Investigational Site
Blagoevgrad, 2700, Bulgaria
GSK Investigational Site
Dobrich, 9300, Bulgaria
GSK Investigational Site
Gabrovo, 5300, Bulgaria
GSK Investigational Site
Lom, 3600, Bulgaria
GSK Investigational Site
Lovech, 5500, Bulgaria
GSK Investigational Site
Montana, 3400, Bulgaria
GSK Investigational Site
Pazardzhik, 4400, Bulgaria
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Plovdiv, 4003, Bulgaria
GSK Investigational Site
Rousse, 7002, Bulgaria
GSK Investigational Site
Smolyan, 4700, Bulgaria
GSK Investigational Site
Sofia, 1233, Bulgaria
GSK Investigational Site
Sofia, 1309, Bulgaria
GSK Investigational Site
Sofia, 1709, Bulgaria
GSK Investigational Site
Varna, 9000, Bulgaria
GSK Investigational Site
Veliko Tarnovo, 5000, Bulgaria
GSK Investigational Site
Edmonton, Alberta, T6G 2B7, Canada
GSK Investigational Site
London, Ontario, N6A 5A5, Canada
GSK Investigational Site
Toronto, Ontario, M3M 0B2, Canada
GSK Investigational Site
Beroun, 26601, Czechia
GSK Investigational Site
Frýdek-mistek, 738 18, Czechia
GSK Investigational Site
Ivančice, 664 95, Czechia
GSK Investigational Site
Jilemnice, 514 01, Czechia
GSK Investigational Site
Mariánské Lázně, 353 01, Czechia
GSK Investigational Site
Pardubice, 53203, Czechia
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Prague, 14021, Czechia
GSK Investigational Site
Prague, 142 00, Czechia
GSK Investigational Site
Sokolov, 356 01, Czechia
GSK Investigational Site
Aalborg, DK-9000, Denmark
GSK Investigational Site
Holstebro, 7500, Denmark
GSK Investigational Site
Kolding, 6000, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Svendborg, 5700, Denmark
GSK Investigational Site
Pärnu, 80011, Estonia
GSK Investigational Site
Tallinn, EE-13419, Estonia
GSK Investigational Site
Tartu, 50501, Estonia
GSK Investigational Site
Annonay, 07103, France
GSK Investigational Site
Bois-Guillaume, 76230, France
GSK Investigational Site
Bordeaux, 33076, France
GSK Investigational Site
Boulogne-Billancourt, 92100, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Mulhouse, 68100, France
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Poitiers, 86021, France
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Reims, 51092, France
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Tours, 37044, France
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Bad König, Hesse, 64732, Germany
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Wiesbaden, Hesse, 65191, Germany
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Cloppenburg, Lower Saxony, 49661, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18059, Germany
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Düsseldorf, North Rhine-Westphalia, 40210, Germany
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Kaiserslautern, Rhineland-Palatinate, 67655, Germany
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Kiel, Schleswig-Holstein, 24105, Germany
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Dieburg, 64807, Germany
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Freiburg im Breisgau, 79110, Germany
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Minden, 32429, Germany
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Alexandroupoli, 68100, Greece
GSK Investigational Site
Arta, 471 00, Greece
GSK Investigational Site
Athens, 11527, Greece
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Heraklion-Crete, 71110, Greece
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Ioannina, 45001, Greece
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Ioannina, 45500, Greece
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Komotini, 69100, Greece
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Larissa, 41110, Greece
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Pátrai, 26500, Greece
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Thessaloniki, 546 42, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 56403, Greece
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Thessaloniki, 57001, Greece
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Budapest, 1077, Hungary
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Eger, 3300, Hungary
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Esztergom, 2500, Hungary
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Kecskemét, 6001, Hungary
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Miskolc, 3526, Hungary
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Pécs, 7624, Hungary
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Pécs, 7633, Hungary
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Szigetvár, 7900, Hungary
GSK Investigational Site
Ahmedabad, 380059, India
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Bangalore, 560054, India
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Bangalore, 560055, India
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Calicut, 673008, India
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Chennai, 600 034, India
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Chennai, Tamil Nadu, 600 006, India
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Delhi, 110076, India
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Gūrgaon, 122001, India
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Hyderabad, 500034, India
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Jaipur, 302004, India
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Mumbai, 400016, India
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Nadiād, 387001, India
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Nagpur, 440010, India
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New Delhi, 110017, India
GSK Investigational Site
New Delhi, 110025, India
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New Delhi, 110060, India
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Pune, 411004, India
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Pune, 411033, India
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Secunderabad, 560020, India
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Trivandrum, 695011, India
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Foggia, Apulia, 71100, Italy
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Catanzaro, Calabria, 88100, Italy
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Reggio Calabria, Calabria, 89124, Italy
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Napoli, Campania, 80131, Italy
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Piacenza, Emilia-Romagna, 29100, Italy
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Genoa, Liguria, 16132, Italy
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Bergamo, Lombardy, 24127, Italy
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Lecco, Lombardy, 23900, Italy
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Milan, Lombardy, 20153, Italy
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Monza, Lombardy, 20900, Italy
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Pavia, Lombardy, 27100, Italy
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Seriate, Lombardy, 24068, Italy
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Turin, Piedmont, 10154, Italy
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Cagliari, Sardinia, 09100, Italy
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Imola, 40026, Italy
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Mestre, 30122, Italy
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Batu Caves, 68100, Malaysia
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George Town, 10990, Malaysia
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Ipoh, 30990, Malaysia
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Johor Bahru, 80100, Malaysia
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Kuala Lumpur, 50603, Malaysia
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Kuala Pahang, 28000, Malaysia
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Saltillo, Coahuila, CP 25230, Mexico
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Durango, Durango, 34000, Mexico
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Guadalajara, Jalisco, 44620, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44650, Mexico
GSK Investigational Site
Querétaro City, Querétaro, 76000, Mexico
GSK Investigational Site
Ciudad de México, State of Mexico, 14000, Mexico
GSK Investigational Site
Cuautitlán Izcalli, State of Mexico, 54769, Mexico
GSK Investigational Site
Mérida, Yucatán, 97070, Mexico
GSK Investigational Site
Aguascalientes, 20230, Mexico
GSK Investigational Site
Chihuahua City, 31203, Mexico
GSK Investigational Site
Chihuahua City, 31217, Mexico
GSK Investigational Site
México, D.F., 14080, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45030, Mexico
GSK Investigational Site
Amsterdam, 1081 HV, Netherlands
GSK Investigational Site
Deventer, 7416 SE, Netherlands
GSK Investigational Site
Rotterdam, 3079 DZ, Netherlands
GSK Investigational Site
Hamilton, 2001, New Zealand
GSK Investigational Site
Hastings, 4156, New Zealand
GSK Investigational Site
Otahuhu, 1640, New Zealand
GSK Investigational Site
Oslo, 0405, Norway
GSK Investigational Site
Stavanger, 4011, Norway
GSK Investigational Site
Biała Podlaska, 21-500, Poland
GSK Investigational Site
Gdansk, 80-462, Poland
GSK Investigational Site
Grójec, 05-600, Poland
GSK Investigational Site
Kielce, 25-736, Poland
GSK Investigational Site
Koło, 62-600, Poland
GSK Investigational Site
Kołobrzeg, 78-100, Poland
GSK Investigational Site
Lodz, 90-262, Poland
GSK Investigational Site
Lodz, 92-213, Poland
GSK Investigational Site
Olkusz, 32-300, Poland
GSK Investigational Site
Pruszków, 05-800, Poland
GSK Investigational Site
Tomaszów Mazowiecki, 97-200, Poland
GSK Investigational Site
Warsaw, 02-758, Poland
GSK Investigational Site
Żary, 68-200, Poland
GSK Investigational Site
Amadora, 2700-391, Portugal
GSK Investigational Site
Corroios, 2855227, Portugal
GSK Investigational Site
Covilha, 6200-000, Portugal
GSK Investigational Site
Forte Da Casa, 2625-437, Portugal
GSK Investigational Site
Lisbon, 1069-166, Portugal
GSK Investigational Site
Lisbon, 1250-203, Portugal
GSK Investigational Site
Lisbon, 1400-195, Portugal
GSK Investigational Site
Lisbon, 1750-130, Portugal
GSK Investigational Site
Mirandela, 5370-530, Portugal
GSK Investigational Site
Portimão, 8500-311, Portugal
GSK Investigational Site
Vila Franca de Xira, 2600-076, Portugal
GSK Investigational Site
Vila Real (Lordelo), 5000-668, Portugal
GSK Investigational Site
Arad, 310141, Romania
GSK Investigational Site
Bucharest, 022328, Romania
GSK Investigational Site
Reşiţa, 320166, Romania
GSK Investigational Site
Târgu Jiu, 210146, Romania
GSK Investigational Site
Irkutsk, 664049, Russia
GSK Investigational Site
Krasnodar, 350029, Russia
GSK Investigational Site
Mytischi, 141009, Russia
GSK Investigational Site
Nizhny Novgorod, 603126, Russia
GSK Investigational Site
Novosibirsk, 630087, Russia
GSK Investigational Site
Omsk, 644112, Russia
GSK Investigational Site
Orenburg, 460040, Russia
GSK Investigational Site
Penza, 440034, Russia
GSK Investigational Site
Saint Petersburg, 191104, Russia
GSK Investigational Site
Saint Petersburg, 194354, Russia
GSK Investigational Site
Saint Petersburg, 196247, Russia
GSK Investigational Site
Saint Petersburg, 197110, Russia
GSK Investigational Site
Volzhsky, 404120, Russia
GSK Investigational Site
Yaroslavl, 150062, Russia
GSK Investigational Site
Singapore, 119074, Singapore
GSK Investigational Site
Singapore, 169608, Singapore
GSK Investigational Site
Singapore, 308433, Singapore
GSK Investigational Site
Cape Town, 7500, South Africa
GSK Investigational Site
Cape Town, 7925, South Africa
GSK Investigational Site
Anyang-Si, Gyeonggi-do, 14068, South Korea
GSK Investigational Site
Bucheon-si, 14647, South Korea
GSK Investigational Site
Busan, 48108, South Korea
GSK Investigational Site
Daegu, 42601, South Korea
GSK Investigational Site
Daejeon, 35233, South Korea
GSK Investigational Site
Goyang-si, 10475, South Korea
GSK Investigational Site
Goyang-si, 410-719, South Korea
GSK Investigational Site
Goyang-si, Gyeonggi-do, 411706, South Korea
GSK Investigational Site
Gyeonggi-do, 463-707, South Korea
GSK Investigational Site
Incheon, 405-760, South Korea
GSK Investigational Site
Seoul, 05030, South Korea
GSK Investigational Site
Seoul, 05355, South Korea
GSK Investigational Site
Seoul, 07061, South Korea
GSK Investigational Site
Seoul, 07441, South Korea
GSK Investigational Site
Seoul, 134-727, South Korea
GSK Investigational Site
Seoul, 135-720, South Korea
GSK Investigational Site
Seoul, 150-713, South Korea
GSK Investigational Site
Seoul, 158-710, South Korea
GSK Investigational Site
Suwon, 442-723, South Korea
GSK Investigational Site
Uijeongbu-si, 11765, South Korea
GSK Investigational Site
Wŏnju, 26426, South Korea
GSK Investigational Site
Majadahonda, Madrid, 28222, Spain
GSK Investigational Site
Alcalá de Henares, 28805, Spain
GSK Investigational Site
Aranda de Duero, 09400, Spain
GSK Investigational Site
Badalona, 08036, Spain
GSK Investigational Site
Badalona, 08916, Spain
GSK Investigational Site
Barcelona, 08003, Spain
GSK Investigational Site
Barcelona, 08025, Spain
GSK Investigational Site
Ciudad Real, 13005, Spain
GSK Investigational Site
Girona, 17007, Spain
GSK Investigational Site
Guadalajara, 19002, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28020, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Manises (Valencia), 46940, Spain
GSK Investigational Site
Málaga, 29530, Spain
GSK Investigational Site
Mollet del Vallès, 08100, Spain
GSK Investigational Site
Palma de Mallorca, 07120, Spain
GSK Investigational Site
Sabadell, 08208, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41071, Spain
GSK Investigational Site
Valladolid, 47005, Spain
GSK Investigational Site
Örebro, SE-701 85, Sweden
GSK Investigational Site
Stockholm, SE-141 86, Sweden
GSK Investigational Site
Stockholm, SE-182 88, Sweden
GSK Investigational Site
Uppsala, 756 55, Sweden
GSK Investigational Site
Kaohsiung City, 807, Taiwan
GSK Investigational Site
Kaohsiung City, 83301, Taiwan
GSK Investigational Site
Keelung, 204, Taiwan
GSK Investigational Site
New Taipei City, 220, Taiwan
GSK Investigational Site
New Taipei City, 23561, Taiwan
GSK Investigational Site
New Taipei City, 237, Taiwan
GSK Investigational Site
Tainan, 704, Taiwan
GSK Investigational Site
Taipei, 112, Taiwan
GSK Investigational Site
Taipei, 116, Taiwan
GSK Investigational Site
Taoyuan Hsien, 333, Taiwan
GSK Investigational Site
Zhongzheng Dist., Taipei, 10002, Taiwan
GSK Investigational Site
Adana, 01330, Turkey (Türkiye)
GSK Investigational Site
Ankara, 06100, Turkey (Türkiye)
GSK Investigational Site
Antalya, 07059, Turkey (Türkiye)
GSK Investigational Site
Edirne, 22030, Turkey (Türkiye)
GSK Investigational Site
Eskişehir, 26480, Turkey (Türkiye)
GSK Investigational Site
Kayseri, 38039, Turkey (Türkiye)
GSK Investigational Site
Chernihiv, 14029, Ukraine
GSK Investigational Site
Chernivtsi, 58005, Ukraine
GSK Investigational Site
Ivano-Frankivsk, 76008, Ukraine
GSK Investigational Site
Kherson, 73039, Ukraine
GSK Investigational Site
Kiev, 04107, Ukraine
GSK Investigational Site
Kyiv, 01023, Ukraine
GSK Investigational Site
Kyiv, 04050, Ukraine
GSK Investigational Site
Kyiv, 04112, Ukraine
GSK Investigational Site
Mykolaiv, 54058, Ukraine
GSK Investigational Site
Ternopil, 46002, Ukraine
GSK Investigational Site
Zaporizhzhia, 69001, Ukraine
GSK Investigational Site
Zaporizhzhia, 69600, Ukraine
GSK Investigational Site
Zhytomyr, 10002, Ukraine
GSK Investigational Site
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
GSK Investigational Site
Preston, Lancashire, PR2 9HT, United Kingdom
GSK Investigational Site
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
GSK Investigational Site
Birmingham, B9 5SS, United Kingdom
GSK Investigational Site
Derby, DE22 3NE, United Kingdom
GSK Investigational Site
Doncaster, DN2 5LT, United Kingdom
GSK Investigational Site
Dundee, DD1 9SY, United Kingdom
GSK Investigational Site
Fife, KY2 5AH, United Kingdom
GSK Investigational Site
Glasgow, G51 4TF, United Kingdom
GSK Investigational Site
Hull, HU3 2JZ, United Kingdom
GSK Investigational Site
London, E1 1BB, United Kingdom
GSK Investigational Site
London, SE5 9RS, United Kingdom
GSK Investigational Site
Oxford, OX3 7LE, United Kingdom
GSK Investigational Site
Salford, M6 8HD, United Kingdom
Related Publications (6)
Cunningham JW, Claggett BL, Lopes RD, McMurray JJV, Perkovic V, Carroll K, Hiemstra T, Khavandi K, Lukas MA, Ranganathan P, Shannon J, van Adelsberg J, Singh AK, Solomon SD. Daprodustat and Heart Failure in CKD. J Am Soc Nephrol. 2024 May 1;35(5):607-617. doi: 10.1681/ASN.0000000000000321. Epub 2024 Feb 22.
PMID: 38383961DERIVEDMacdougall IC, Meadowcroft AM, Blackorby A, Cizman B, Cobitz AR, Godoy S, Jha V, Johansen KL, McMahon G, Obrador GT, Wong MG, Singh AK. Regional Variation of Erythropoiesis-Stimulating Agent Hyporesponsiveness in the Global Daprodustat Dialysis Study (ASCEND-D). Am J Nephrol. 2023;54(1-2):1-13. doi: 10.1159/000528696. Epub 2023 Feb 7.
PMID: 36739866DERIVEDSingh AK, McCausland FR, Claggett BL, Wanner C, Wiecek A, Atkins MB, Carroll K, Perkovic V, McMurray JJV, Wittes J, Snapinn S, Blackorby A, Meadowcroft A, Barker T, DiMino T, Mallett S, Cobitz AR, Solomon SD. Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents-post hoc analyses of the ASCEND-ND and ASCEND-D trials. Nephrol Dial Transplant. 2023 Jul 31;38(8):1890-1897. doi: 10.1093/ndt/gfac342.
PMID: 36565721DERIVEDNatale 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: 36005278DERIVEDSingh AK, Carroll K, Perkovic V, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, Dole J, Kler L, Meadowcroft AM, Zhu X, McMurray JJV; ASCEND-D Study Group. Daprodustat for the Treatment of Anemia in Patients Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2325-2335. doi: 10.1056/NEJMoa2113379. Epub 2021 Nov 5.
PMID: 34739194DERIVEDSingh AK, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Perkovic V, Solomon S, Wanner C, Waikar SS, Wheeler DC, Wiecek A. Study design and baseline characteristics of patients on dialysis in the ASCEND-D trial. Nephrol Dial Transplant. 2022 Apr 25;37(5):960-972. doi: 10.1093/ndt/gfab065.
PMID: 33744933DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2016
First Posted
August 25, 2016
Study Start
September 28, 2016
Primary Completion
November 9, 2020
Study Completion
November 9, 2020
Last Updated
December 3, 2021
Results First Posted
December 3, 2021
Record last verified: 2021-11