Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa
2 other identifiers
interventional
3,872
38 countries
571
Brief Summary
The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
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
Longer than P75 for phase_3
571 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 19, 2016
CompletedFirst Posted
Study publicly available on registry
August 24, 2016
CompletedStudy Start
First participant enrolled
September 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2021
CompletedResults Posted
Study results publicly available
April 14, 2022
CompletedApril 2, 2024
March 1, 2024
4.6 years
August 19, 2016
February 15, 2022
April 1, 2024
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 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, current erythropoiesis-stimulating agents (ESA) use at randomization 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 \[\*\] 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 4.3 person-years for CV follow-up time period
Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52)
Blood samples were collected from participants for Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb 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. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.
Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)
Secondary Outcomes (39)
Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)
Up to 4.3 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 4.3 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 4.3 person-years for CV follow-up time period
Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period
Up to 4.3 person-years for CV follow-up time period
Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period
Up to 4.3 person-years for vital status follow-up time period
- +34 more secondary outcomes
Study Arms (2)
Daprodustat
EXPERIMENTALParticipants will receive oral daprodustat once daily.
Darbepoetin alfa
ACTIVE COMPARATORParticipants will be administered darbepoetin alfa subcutaneously (SC).
Interventions
The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.
The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.
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)
- CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.
- Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.
- For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.
- \>=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.
You may not qualify if:
- Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (574)
GSK Investigational Site
Andalusia, Alabama, 36420, United States
GSK Investigational Site
Birmingham, Alabama, 35249, United States
GSK Investigational Site
Huntsville, Alabama, 35805, United States
GSK Investigational Site
Glendale, Arizona, 85305, United States
GSK Investigational Site
Mesa, Arizona, 85202, United States
GSK Investigational Site
Phoenix, Arizona, 85016, United States
GSK Investigational Site
Phoenix, Arizona, 85027, United States
GSK Investigational Site
Scottsdale, Arizona, 48201, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Azusa, California, 91702, United States
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Bakersfield, California, 93308, United States
GSK Investigational Site
Bakersfield, California, 93309, United States
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Chula Vista, California, 91910, United States
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Cudahy, California, 90201, 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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Glendale, California, 91204, United States
GSK Investigational Site
Granada Hills, California, 91344, United States
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La Mesa, California, 91942, United States
GSK Investigational Site
La Palma, California, 90623, United States
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Long Beach, California, 90806, United States
GSK Investigational Site
Los Angeles, California, 90022, United States
GSK Investigational Site
Los Angeles, California, 90095, United States
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Montebello, California, 90640, United States
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National City, California, 91950, United States
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Riverside, California, 92505, United States
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San Diego, California, 92103, United States
GSK Investigational Site
San Diego, California, 92111, United States
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San Luis Obispo, California, 93405, 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, 90602, 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
GSK Investigational Site
Boca Raton, Florida, 33431, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Cutler Bay, Florida, 33189, United States
GSK Investigational Site
Doral, Florida, 33122, United States
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Fort Lauderdale, Florida, 33308, United States
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Homestead, Florida, 33033, United States
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Hudson, Florida, 34667, United States
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Jacksonville, Florida, 32224, United States
GSK Investigational Site
Jacksonville, Florida, 32256, United States
GSK Investigational Site
Lauderdale Lakes, Florida, 33313, United States
GSK Investigational Site
Miami, Florida, 33126, United States
GSK Investigational Site
Miami, Florida, 33143, United States
GSK Investigational Site
Miami, Florida, 33145, United States
GSK Investigational Site
Miami, Florida, 33147, United States
GSK Investigational Site
Miami, Florida, 33150, United States
GSK Investigational Site
Miami, Florida, 33155, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Miami, Florida, 33165, United States
GSK Investigational Site
Miami, Florida, 33169, United States
GSK Investigational Site
Miami, Florida, 33173, United States
GSK Investigational Site
Miami Gardens, Florida, 33169, United States
GSK Investigational Site
Miami Lakes, Florida, 33014, United States
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Ocala, Florida, 34471, United States
GSK Investigational Site
Orlando, Florida, 32810, United States
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Pembroke Pines, Florida, 33028, United States
GSK Investigational Site
Port Charlotte, Florida, 33952, United States
GSK Investigational Site
South Miami, Florida, 33143, United States
GSK Investigational Site
Tampa, Florida, 33612, United States
GSK Investigational Site
Temple Terrace, Florida, 33637, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Augusta, Georgia, 30904, United States
GSK Investigational Site
Augusta, Georgia, 30909, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Nampa, Idaho, 83687, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Chicago, Illinois, 60643, United States
GSK Investigational Site
Crystal Lake, Illinois, 60014, United States
GSK Investigational Site
Mount Prospect, Illinois, 60056, United States
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Quincy, Illinois, 62301, United States
GSK Investigational Site
Springfield, Illinois, 62702, United States
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Fort Wayne, Indiana, 46845, United States
GSK Investigational Site
Jeffersonville, Indiana, 47130, United States
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Michigan City, Indiana, 46360, United States
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Des Moines, Iowa, 50309, United States
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Iowa City, Iowa, 52242, United States
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Hutchinson, Kansas, 67502, United States
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Wichita, Kansas, 67214, 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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Metairie, Louisiana, 70006, United States
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Baltimore, Maryland, 21287, United States
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Potomac, Maryland, 20854, United States
GSK Investigational Site
Takoma Park, Maryland, 20912-6385, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48202, United States
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Kalamazoo, Michigan, 49007, United States
GSK Investigational Site
Pontiac, Michigan, 48341, United States
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Minneapolis, Minnesota, 55414, United States
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Jackson, Mississippi, 39216, United States
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Tupelo, Mississippi, 38801, United States
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St Louis, Missouri, 63106, United States
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St Louis, Missouri, 63110, United States
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North Platte, Nebraska, 69101, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
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Brooklyn, New York, 11203, United States
GSK Investigational Site
Buffalo, New York, 14215, United States
GSK Investigational Site
Flushing, New York, 11355, United States
GSK Investigational Site
Laurelton, New York, 11413, United States
GSK Investigational Site
New York, New York, 10021, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Ridgewood, New York, 11385, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
The Bronx, New York, 10467, United States
GSK Investigational Site
Yonkers, New York, 10704, United States
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Charlotte, North Carolina, 28204, United States
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Raleigh, North Carolina, 27609, United States
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Rocky Mount, North Carolina, 27804, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Grand Forks, North Dakota, 58201, United States
GSK Investigational Site
Canton, Ohio, 15212, United States
GSK Investigational Site
Cincinnati, Ohio, 45206, United States
GSK Investigational Site
Cincinnati, Ohio, 45220, United States
GSK Investigational Site
Mentor, Ohio, 44060, United States
GSK Investigational Site
Lawton, Oklahoma, 73505, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Roseburg, Oregon, 97471, United States
GSK Investigational Site
Bethlehem, Pennsylvania, 18017, United States
GSK Investigational Site
Doylestown, Pennsylvania, 18901, United States
GSK Investigational Site
Lancaster, Pennsylvania, 17601, United States
GSK Investigational Site
Upland, Pennsylvania, 19013, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29425, United States
GSK Investigational Site
Columbia, South Carolina, 29209, United States
GSK Investigational Site
Sumter, South Carolina, 29150, United States
GSK Investigational Site
Cordova, Tennessee, 38018, United States
GSK Investigational Site
Knoxville, Tennessee, 37923, United States
GSK Investigational Site
Memphis, Tennessee, 38163, United States
GSK Investigational Site
Nashville, Tennessee, 37205, United States
GSK Investigational Site
Arlington, Texas, 76002, United States
GSK Investigational Site
Austin, Texas, 78751, United States
GSK Investigational Site
Austin, Texas, 78758, United States
GSK Investigational Site
Corpus Christi, Texas, 78404, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Dallas, Texas, 75237, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Houston, Texas, 77004, United States
GSK Investigational Site
Houston, Texas, 77043, United States
GSK Investigational Site
Houston, Texas, 77084, United States
GSK Investigational Site
Houston, Texas, 77099, United States
GSK Investigational Site
Lufkin, Texas, 75904, United States
GSK Investigational Site
McAllen, Texas, 78503, United States
GSK Investigational Site
San Antonio, Texas, 78202, United States
GSK Investigational Site
San Antonio, Texas, 78212, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
San Antonio, Texas, 78258, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Waxahachie, Texas, 75165, United States
GSK Investigational Site
Alexandria, Virginia, 22304, United States
GSK Investigational Site
Fairfax, Virginia, 22033, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Salem, Virginia, 24153, United States
GSK Investigational Site
Bluefield, West Virginia, 24701, United States
GSK Investigational Site
Ciudad Evita, Buenos Aires, B1778IFA, Argentina
GSK Investigational Site
Coronel Suárez, Buenos Aires, 7540, Argentina
GSK Investigational Site
Junín, Buenos Aires, B6000GMA, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600, Argentina
GSK Investigational Site
Pergamino, Buenos Aires, B2700CPM, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, 5000, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5016KEH, Argentina
GSK Investigational Site
Buenos Aires, 1425, Argentina
GSK Investigational Site
Buenos Aires, C1181ACH, Argentina
GSK Investigational Site
Buenos Aires, CP1431FWO, Argentina
GSK Investigational Site
Corrientes, W3400AMZ, Argentina
GSK Investigational Site
Formosa, P3600LLD, Argentina
GSK Investigational Site
La Plata, B1902COS, Argentina
GSK Investigational Site
Mendoza, M5500AFA, Argentina
GSK Investigational Site
Morón, B1708DPO, Argentina
GSK Investigational Site
San Miguel de Tucumán, T4000AHL, Argentina
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Concord, New South Wales, 2139, Australia
GSK Investigational Site
Gosford, New South Wales, 2250, Australia
GSK Investigational Site
Kingswood, New South Wales, 2747, Australia
GSK Investigational Site
Kogarah, New South Wales, 2217, Australia
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
St Leonards, New South Wales, 2065, Australia
GSK Investigational Site
Wollongong, New South Wales, 2500, Australia
GSK Investigational Site
Nambour, Queensland, 4560, Australia
GSK Investigational Site
Melbourne, Victoria, 3004, Australia
GSK Investigational Site
Reservoir, Victoria, 3073, Australia
GSK Investigational Site
St Albans, Victoria, 3021, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Liverpool, 2107, Australia
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Baudour, 7331, Belgium
GSK Investigational Site
Bruges, 8310, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Ieper, 8900, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Roeselare, 8800, Belgium
GSK Investigational Site
Ronse, 9600, Belgium
GSK Investigational Site
Sint-Niklaas, 9100, Belgium
GSK Investigational Site
Salvador, Estado de Bahia, 40415-065, Brazil
GSK Investigational Site
Curitiba, Paraná, 80440-020, Brazil
GSK Investigational Site
Curitiba, Paraná, 80730-150, 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, 90035-074, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
GSK Investigational Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
GSK Investigational Site
Votuporanga, São Paulo, 15500-003, Brazil
GSK Investigational Site
Belo Horizonte, 30150-320, Brazil
GSK Investigational Site
Brasília, 70840-901, Brazil
GSK Investigational Site
Feira de Santana, 44001-465, Brazil
GSK Investigational Site
Joinville, 89201-010, Brazil
GSK Investigational Site
Juiz de Fora, 36036-330, Brazil
GSK Investigational Site
São Paulo, 01323903, Brazil
GSK Investigational Site
São Paulo, 04039-000, Brazil
GSK Investigational Site
São Paulo, ?01323-001, Brazil
GSK Investigational Site
São Paulo, ?04005-000, Brazil
GSK Investigational Site
São Paulo, ?08270-070, Brazil
GSK Investigational Site
Blagoevgrad, 2700, Bulgaria
GSK Investigational Site
Burgas, 8000, Bulgaria
GSK Investigational Site
Dobrich, 9300, Bulgaria
GSK Investigational Site
Gabrovo, 5300, Bulgaria
GSK Investigational Site
Lom, 3600, Bulgaria
GSK Investigational Site
Pazardzhik, 4400, Bulgaria
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Sliven, 8800, Bulgaria
GSK Investigational Site
Smolyan, 4700, Bulgaria
GSK Investigational Site
Sofia, 1233, Bulgaria
GSK Investigational Site
Sofia, 1709, Bulgaria
GSK Investigational Site
Stara Zagora, 6000, 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
Halifax, Nova Scotia, B3H 1V8, Canada
GSK Investigational Site
Brampton, Ontario, L6T 0G1, Canada
GSK Investigational Site
London, Ontario, N6A 5A5, Canada
GSK Investigational Site
Mississauga, Ontario, L4V 1P1, Canada
GSK Investigational Site
Mississauga, Ontario, L5M 2V8, Canada
GSK Investigational Site
Toronto, Ontario, M4C 5T2, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1, Canada
GSK Investigational Site
Montreal, Quebec, H3G 1A4, Canada
GSK Investigational Site
Québec, Quebec, G1R 2J6, Canada
GSK Investigational Site
Barranquilla, 760002, Colombia
GSK Investigational Site
Bogotá, 111711, Colombia
GSK Investigational Site
Cali, 760007, Colombia
GSK Investigational Site
Floridablanca, 681001, Colombia
GSK Investigational Site
Medellín, 050012, Colombia
GSK Investigational Site
Beroun, 26601, Czechia
GSK Investigational Site
Český Krumlov, 38127, 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
Nový Jičín, 74101, Czechia
GSK Investigational Site
Pardubice, 53203, Czechia
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Prague, 140 21, 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
Jämejala Village, 71024, Estonia
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Tallinn, EE-13419, Estonia
GSK Investigational Site
Tartu, 50501, Estonia
GSK Investigational Site
Annonay, 07103, France
GSK Investigational Site
Boulogne-Billancourt, 92100, France
GSK Investigational Site
Caen, 14033, France
GSK Investigational Site
Clermont-Ferrand, 63000, France
GSK Investigational Site
Lyon, 69003, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Mulhouse, 68100, France
GSK Investigational Site
Poitiers, 86021, France
GSK Investigational Site
Saint-Ouen, 93400, France
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Munich, Bavaria, 81675, Germany
GSK Investigational Site
Cloppenburg, Lower Saxony, 49661, Germany
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40210, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48149, Germany
GSK Investigational Site
Kaiserslautern, Rhineland-Palatinate, 67655, Germany
GSK Investigational Site
Leipzig, Saxony, 04129, Germany
GSK Investigational Site
Cologne, 50937, Germany
GSK Investigational Site
Wiesbaden, 65191, Germany
GSK Investigational Site
Alexandroupoli, 68100, Greece
GSK Investigational Site
Arta, 471 00, Greece
GSK Investigational Site
Athens, 115 26, Greece
GSK Investigational Site
Athens, 11526, Greece
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Athens, 12462, Greece
GSK Investigational Site
Efkarpia, 564 29, Greece
GSK Investigational Site
Heraklion-Crete, 71110, Greece
GSK Investigational Site
Ioannina, 45001, Greece
GSK Investigational Site
Ioannina, 45500, Greece
GSK Investigational Site
Komotini, 69100, Greece
GSK Investigational Site
Larissa, 41100, Greece
GSK Investigational Site
Melíssia, 15127, Greece
GSK Investigational Site
Pátrai, 26500, Greece
GSK Investigational Site
Thessaloniki, 546 42, Greece
GSK Investigational Site
Thessaloniki, 54636, Greece
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Related Publications (6)
Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196
BACKGROUNDPerkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.
PMID: 34865143BACKGROUNDCunningham 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: 38383961DERIVEDSingh 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, McMurray JJV, 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, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.
PMID: 34739196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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 19, 2016
First Posted
August 24, 2016
Study Start
September 27, 2016
Primary Completion
April 19, 2021
Study Completion
April 19, 2021
Last Updated
April 2, 2024
Results First Posted
April 14, 2022
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
- Access Criteria
- Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/