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Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02879305
Recruitment Status : Active, not recruiting
First Posted : August 25, 2016
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Anaemia Drug: Daprodustat Drug: rhEPO Drug: Placebo Drug: Iron therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2968 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 28, 2016
Estimated Primary Completion Date : April 14, 2020
Estimated Study Completion Date : April 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daprodustat
Participants will receive oral daprodustat once daily.
Drug: Daprodustat
Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.

Drug: Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

Drug: Iron therapy
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.

Active Comparator: rhEPO
Participants on peritoneal dialysis (PD) will be administered darbepoetin alfa subcutaneously (SC) and participants on hemodialysis (HD) will be administered epoetin alfa intravenously (IV).
Drug: rhEPO
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.

Drug: Placebo
Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).

Drug: Iron therapy
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.




Primary Outcome Measures :
  1. Time to the first occurrence of adjudicated major adverse cardiovascular event (MACE) (composite of all-cause mortality, non-fatal myocardial infarction [MI] and non-fatal stroke) [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  2. Mean change in hemoglobin (Hgb) between Baseline and efficacy period (EP) (mean over Weeks 28-52) [ Time Frame: Baseline and up to and including Week 52 ]

Secondary Outcome Measures :
  1. Time to first occurrence of adjudicated MACE [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  2. Time to first occurrence of adjudicated MACE or a thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  3. Time to first occurrence of adjudicated MACE or a hospitalization for heart failure (HF) [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  4. Average monthly intravenous (IV) iron dose milligram (mg) per subject to Week 52 [ Time Frame: Up to and including Week 52 ]
  5. Time to first occurrence of all-cause mortality, cardiovascular (CV) mortality, fatal or non-fatal MI, fatal or non-fatal stroke [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  6. Time to first occurrence of MACE or hospitalization for HF (recurrent events analysis) [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  7. Time to first occurrence of CV death or non fatal MI incidences [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  8. Time to first occurrence of all-cause hospitalization [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  9. Time to first occurrence of all cause hospital re-admission within 30 days [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  10. Time to first occurrence of MACE or hospitalization for HF or thromboembolic events [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  11. Time to first occurrence of Hospitalization for HF [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  12. Time to first occurrence of Thromboembolic events [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  13. Hgb change from Baseline to Week 52 [ Time Frame: Baseline, and up to and including Week 52 ]
  14. Percentage of responders, defined as mean Hgb within Hgb analysis range [ Time Frame: Up to and including Week 52 ]
  15. Number of responders, defined as mean Hgb within Hgb analysis range [ Time Frame: Up to and including Week 52 ]
  16. Percentage time for which Hgb is in analysis range during the EP (Week 28 to 52) and during the maintenance period (MP; Week 28 to end of trial) [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  17. Change from Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52 and at end of treatment [ Time Frame: Baseline and up to 3.3 years ]
  18. Number of blood pressure (BP) exacerbation events per 100 patient years [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  19. Number of participants with least one BP exacerbation event during study [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  20. Percentage of participants with least one BP exacerbation event during study [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  21. Time to stopping randomized treatment due to meeting rescue criteria [ Time Frame: Randomization (Day 1) to end of study (event-driven, up to 3.3 years) ]
  22. Mean change in SF-36 Health Related Quality of Life (HRQOL) scores between Baseline and Weeks 8, 12, 28, 52, of particular interest are the changes from Baseline in the vitality and physical functioning domains at Weeks 28 and 52 [ Time Frame: Baseline, and up to and including Week 52 ]
  23. Change from Baseline in EuroQol 5 Dimension 5 Level Health Utility Index (EQ-5D-5L) score at Week 52 [ Time Frame: Baseline, and up to and including Week 52 ]
  24. Change from Baseline in EQ-5D-5L visual analog scale (VAS) at Week 52 [ Time Frame: Baseline, and up to and including Week 52 ]
  25. Change from Baseline in Patient Global Impression of Severity Scale (PGI-S) at Week 8, 12, 28 and 52 [ Time Frame: Baseline, and up to and including Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • Bazett's corrected QT interval (QTcB) (Day 1): QTcB >500 millisecond (msec), or QTcB >530 msec in subjects with bundle branch block. There is no QT Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.
  • 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.
  • Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).
  • Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1).
  • Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of >30 days.
  • Females only: Subject is pregnant [as confirmed by a positive serum human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options listed in the List of Highly Effective Methods for Avoiding Pregnancy.
  • Other Conditions: Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g., intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02879305


Locations
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United States, Alabama
GSK Investigational Site
Huntsville, Alabama, United States, 35805
United States, Arkansas
GSK Investigational Site
Pine Bluff, Arkansas, United States, 71603
United States, California
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Anaheim, California, United States, 92801
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Bakersfield, California, United States, 93309
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Bakersfield, California, United States, Bakersfield
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Beverly Hills, California, United States, 90211
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Cerritos, California, United States, 90703
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Chula Vista, California, United States, 91910
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El Centro, California, United States
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Escondido, California, United States, 92025
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Fairfield, California, United States, 94534
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Fountain Valley, California, United States, 92708
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Glendale, California, United States, 91204
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Granada Hills, California, United States, 91344
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Hacienda Heights, California, United States, 91745
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La Mesa, California, United States, 91942
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La Palma, California, United States, 90623
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Lakewood, California, United States, 90712
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Long Beach, California, United States, 90806
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Long Beach, California, United States, 90807
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Los Angeles, California, United States, 90022
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Los Angeles, California, United States, 90095
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Lynwood, California, United States, 60262
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Montebello, California, United States, 90640
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Monterey Park, California, United States, 91754
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Moreno Valley, California, United States, 92553
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Norco, California, United States, 92860
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Northridge, California, United States, 91324
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Ontario, California, United States, 91762
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Riverside, California, United States, 92501
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Sacramento, California, United States, 95825
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San Diego, California, United States, 92103
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San Diego, California, United States, 92111
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San Luis Obispo, California, United States, 93405
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Santa Clarita, California, United States, 91387
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Simi Valley, California, United States, 91355
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Tarzana, California, United States, 91356
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Upland, California, United States, 91786
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Whittier, California, United States, 90602
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Whittier, California, United States, 90603
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Yorba Linda, California, United States, 92886
United States, Connecticut
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Middlebury, Connecticut, United States, 06762
United States, District of Columbia
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Washington, District of Columbia, United States, 20037
United States, Florida
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Aventura, Florida, United States, 33180
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Coral Gables, Florida, United States, 33134
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Hollywood, Florida, United States, 33024
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Jacksonville, Florida, United States, 32224
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Lauderdale Lakes, Florida, United States, 33313
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Miami Gardens, Florida, United States, 33169
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33143
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Miami, Florida, United States, 33150
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Miami, Florida, United States, 33156
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Ocala, Florida, United States, 34471
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Port Charlotte, Florida, United States, 33952
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Spring Hill, Florida, United States, 34608
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Winter Park, Florida, United States, 32789
United States, Georgia
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Augusta, Georgia, United States, 30904
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Augusta, Georgia, United States, 30912
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Columbus, Georgia, United States, 31904
United States, Idaho
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Meridian, Idaho, United States, 83642
United States, Illinois
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Crystal Lake, Illinois, United States, 60014
United States, Indiana
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Fort Wayne, Indiana, United States, 46804
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Jeffersonville, Indiana, United States, 47130
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Merrillville, Indiana, United States, 46410
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Michigan City, Indiana, United States, 46360
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kentucky
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Louisville, Kentucky, United States, 40202
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
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Baton Rouge, Louisiana, United States, 70836
United States, Maryland
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Lanham, Maryland, United States, 20706-1872
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Takoma Park, Maryland, United States, 20912-6385
United States, Michigan
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Kalamazoo, Michigan, United States, 49007
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Rochester Hills, Michigan, United States, 48309
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Roseville, Michigan, United States, 48066
United States, Mississippi
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Gulfport, Mississippi, United States, 39501
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Tupelo, Mississippi, United States, 38801
United States, Missouri
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Florissant, Missouri, United States, 63033
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Kansas City, Missouri, United States, 64111
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Saint Louis, Missouri, United States, 63110
United States, Nevada
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Las Vegas, Nevada, United States, 89102
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Las Vegas, Nevada, United States, 89107
United States, New Hampshire
GSK Investigational Site
Portsmouth, New Hampshire, United States, 3801
United States, New Mexico
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Gallup, New Mexico, United States, 87301
United States, New York
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Bronx, New York, United States, 10461
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Brooklyn, New York, United States, 11203
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Buffalo, New York, United States, 14215
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Flushing, New York, United States, 11355
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Mineola, New York, United States, 11501
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New York, New York, United States, 10029
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Ridgewood, New York, United States, 11385
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Yonkers, New York, United States, 10710
United States, North Carolina
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Asheville, North Carolina, United States, 28801
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Clyde, North Carolina, United States, 28721
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Raleigh, North Carolina, United States, 27609
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Winston-Salem, North Carolina, United States, 27103
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Winston-Salem, North Carolina, United States, 27517
United States, Ohio
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Canton, Ohio, United States, 44718
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Cincinnati, Ohio, United States, 45206
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Cincinnati, Ohio, United States, 45220
United States, Oregon
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Roseburg, Oregon, United States, 97471
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18017
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Philadelphia, Pennsylvania, United States, 19140
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
United States, South Carolina
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Anderson, South Carolina, United States, 29621
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Charleston, South Carolina, United States, 29425
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Sumter, South Carolina, United States, 29150
United States, Tennessee
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Cordova, Tennessee, United States, 38018
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Knoxville, Tennessee, United States, 37923
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Knoxville, Tennessee, United States, 37924
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Nashville, Tennessee, United States, 37205
United States, Texas
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Beaumont, Texas, United States, 77701
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Houston, Texas, United States, 77004
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Houston, Texas, United States, 77030
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Houston, Texas, United States, 77099
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Lufkin, Texas, United States, 75904
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San Antonio, Texas, United States, 78207
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San Antonio, Texas, United States, 78221
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78251
United States, Virginia
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Alexandria, Virginia, United States, 22304
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Fairfax, Virginia, United States, 22033
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Hampton, Virginia, United States, 23666
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Salem, Virginia, United States, 24153
United States, West Virginia
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Bluefield, West Virginia, United States, 24701
United States, Wisconsin
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Shorewood, Wisconsin, United States, 53211
Argentina
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Burzaco, Buenos Aires, Argentina, B1852FZD
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Ciudad Evita, Buenos Aires, Argentina, B1778IFA
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Pergamino, Buenos Aires, Argentina, B2700CPM
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Pilar, Buenos Aires, Argentina, 1629
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Córdoba, Córdova, Argentina, X5016KEH
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Buenos Aires, Argentina, 1425
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Buenos Aires, Argentina, C1181ACH
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Buenos Aires, Argentina, CP1431FWO
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Formosa, Argentina, P3600LLD
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Mendoza, Argentina, M5500AFA
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Moron, Argentina, B1708DPO
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San Miguel de Tucumán, Argentina, T4000AHL
Australia, New South Wales
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Concord, New South Wales, Australia, 2139
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Kingswood, New South Wales, Australia, 2750
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Kogarah, New South Wales, Australia, 2217
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Liverpool, New South Wales, Australia, 2170
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St Leonards, New South Wales, Australia, 2065
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Westmead, New South Wales, Australia, 2145
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Wollongong, New South Wales, Australia, 2500
Australia, Queensland
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Birtinya, Queensland, Australia, 4575
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Herston, Queensland, Australia, 4006
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Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
Australia, Victoria
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Clayton, Victoria, Australia, 3168
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Melbourne, Victoria, Australia, 3004
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St Albans, Victoria, Australia, 3021
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
Australia
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Murdoch, Australia, 6150
Austria
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Graz, Austria, 8036
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St. Pölten, Austria, 3100
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Wien, Austria, 1030
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Wien, Austria, 1130
Belgium
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Baudour, Belgium, 7331
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Brugge, Belgium, 8310
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Brussels, Belgium, 1200
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Bruxelles, Belgium, 1020
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Hasselt, Belgium, 3500
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Ieper, Belgium, 8900
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Leuven, Belgium, 3000
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Liège, Belgium, 4000
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Roeselare, Belgium, 8800
Brazil
GSK Investigational Site
Salvador, Bahia, Brazil, 40415-065
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Curitiba, Paraná, Brazil, 80440-020
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Curitiba, Paraná, Brazil, CEP 80230-130
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Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
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Joinville, Santa Catarina, Brazil, 89227-680
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Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
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Belo Horizonte, Minas Gerais, Brazil, 30150-221
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Feira de Santana, Brazil, 44001-584
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Porto Alegre, Brazil, 90035-070
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Sao Paulo, Brazil, 01323-001
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São Paulo, Brazil, 01323903
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São Paulo, Brazil, 04039-000
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São Paulo, Brazil, 04005-000
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São Paulo, Brazil, 08270-070
Bulgaria
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Blagoevgrad, Bulgaria, 2700
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Dobrich, Bulgaria, 9300
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Gabrovo, Bulgaria, 5300
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Lom, Bulgaria, 3600
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Lovech, Bulgaria, 5500
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Montana, Bulgaria, 3400
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Pazardzhik, Bulgaria, 4400
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Plovdiv, Bulgaria, 4000
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Plovdiv, Bulgaria, 4003
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Ruse, Bulgaria, 7002
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Smolyan, Bulgaria, 4700
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1309
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Sofia, Bulgaria, 1431
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Sofia, Bulgaria, 1709
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Varna, Bulgaria, 9000
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Veliko Tarnovo, Bulgaria, 5000
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
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London, Ontario, Canada, N6A 5A5
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Toronto, Ontario, Canada, M6M 3Z5
Czechia
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Beroun, Czechia, 26601
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Frýdek-mistek, Czechia, 738 18
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Ivancice, Czechia, 664 95
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Jilemnice, Czechia, 514 01
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Marianske Lazne, Czechia, 353 01
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Pardubice, Czechia, 53203
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Praha 2, Czechia, 128 08
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Praha 4, Czechia, 14021
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Praha 4, Czechia, 142 00
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Sokolov, Czechia, 356 01
Denmark
GSK Investigational Site
Aalborg, Denmark, DK-9000
GSK Investigational Site
Holstebro, Denmark, 7500
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Kolding, Denmark, 6000
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Odense C, Denmark, 5000
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Svendborg, Denmark, 5700
Estonia
GSK Investigational Site
Parnu, Estonia, 80011
GSK Investigational Site
Tallinn, Estonia, EE-13419
GSK Investigational Site
Tartu, Estonia
France
GSK Investigational Site
Annonay, France, 07103
GSK Investigational Site
Bois-Guillaume, France, 76230
GSK Investigational Site
Bordeaux, France, 33076
GSK Investigational Site
Boulogne Billancourt, France, 92100
GSK Investigational Site
Caen Cedex 9, France, 14033
GSK Investigational Site
La Tronche, France, 38700
GSK Investigational Site
Mulhouse, France, 68100
GSK Investigational Site
Poitiers, France, 86021
GSK Investigational Site
Reims, France, 51092
GSK Investigational Site
Tours cedex 9, France, 37044
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
GSK Investigational Site
Bad Koenig, Hessen, Germany, 64732
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65191
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
GSK Investigational Site
Cloppenburg, Niedersachsen, Germany, 49661
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40210
GSK Investigational Site
Kaiserslautern, Rheinland-Pfalz, Germany, 67655
GSK Investigational Site
Dieburg, Germany, 64807
GSK Investigational Site
Freiburg, Germany, 79110
GSK Investigational Site
Kiel, Germany, 24105
GSK Investigational Site
Minden, Germany, 32429
Greece
GSK Investigational Site
Alexandroupolis, Greece, 68100
GSK Investigational Site
Arta, Greece, 471 00
GSK Investigational Site
Athens, Greece, 11527
GSK Investigational Site
Heralkion, Greece, 71409
GSK Investigational Site
Ioannina, Greece, 45001
GSK Investigational Site
Ioannina, Greece, 45500
GSK Investigational Site
Komotini, Greece, 69 100
GSK Investigational Site
Larissa, Greece, 41110
GSK Investigational Site
Patras, Greece, 26500
GSK Investigational Site
Thessaloniki, Greece, 546 42
GSK Investigational Site
Thessaloniki, Greece, 54636
GSK Investigational Site
Thessaloniki, Greece, 56403
GSK Investigational Site
Thessaloniki, Greece, 57001
Hungary
GSK Investigational Site
Budapest, Hungary, 1077
GSK Investigational Site
Egri, Hungary, 3300
GSK Investigational Site
Esztergom, Hungary, 2500
GSK Investigational Site
Kecskemet, Hungary, 6001
GSK Investigational Site
Miskolc, Hungary, 3526
GSK Investigational Site
Pécs, Hungary, 7624
GSK Investigational Site
Pécs, Hungary, 7633
GSK Investigational Site
Szigetvar, Hungary, 7900
India
GSK Investigational Site
Ahmedabad, India, 380059
GSK Investigational Site
Bangalore, India, 560054
GSK Investigational Site
Bangalore, India, 560055
GSK Investigational Site
Calicut, India, 673008
GSK Investigational Site
Chennai, Tamil Nadu, India, 600 006
GSK Investigational Site
Chennai, India, 600 034
GSK Investigational Site
Delhi, India, 110076
GSK Investigational Site
Gurgaon, India, 122001
GSK Investigational Site
Hyderabad, India, 500034
GSK Investigational Site
Jaipur, India, 302004
GSK Investigational Site
Mumbai, India, 400016
GSK Investigational Site
Nadiad, India, 387001
GSK Investigational Site
Nagpur, India, 440010
GSK Investigational Site
New Delhi, India, 110017
GSK Investigational Site
New Delhi, India, 110025
GSK Investigational Site
New Delhi, India, 110060
GSK Investigational Site
Pune, India, 411004
GSK Investigational Site
Pune, India, 411033
GSK Investigational Site
Secunderabad, India, 560020
GSK Investigational Site
Trivandrum, India, 695011
Italy
GSK Investigational Site
Catanzaro, Calabria, Italy, 88100
GSK Investigational Site
Reggio Calabria, Calabria, Italy, 89124
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
GSK Investigational Site
Genova, Liguria, Italy, 16132
GSK Investigational Site
Bergamo, Lombardia, Italy, 24127
GSK Investigational Site
Lecco, Lombardia, Italy, 23900
GSK Investigational Site
Milano, Lombardia, Italy, 20132
GSK Investigational Site
Milano, Lombardia, Italy, 20153
GSK Investigational Site
Monza, Lombardia, Italy, 20900
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Seriate, Lombardia, Italy, 24068
GSK Investigational Site
Torino, Piemonte, Italy, 10154
GSK Investigational Site
Foggia, Puglia, Italy, 71100
GSK Investigational Site
Cagliari, Sardegna, Italy, 09100
GSK Investigational Site
Imola, Italy, 40026
GSK Investigational Site
Mestre, Italy, 30122
Korea, Republic of
GSK Investigational Site
Anyang-Si, Gyeonggi-do, Korea, Republic of, 14068
GSK Investigational Site
Bucheon-si,, Korea, Republic of, 14647
GSK Investigational Site
Busan, Korea, Republic of, 48108
GSK Investigational Site
Daegu-si, Korea, Republic of, 700-710
GSK Investigational Site
Daejeon, Korea, Republic of, 302-799
GSK Investigational Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 411706
GSK Investigational Site
Goyang-si, Korea, Republic of, 10475
GSK Investigational Site
Goyang-si, Korea, Republic of, 410-719
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 463-707
GSK Investigational Site
Incheon, Korea, Republic of, 405-760
GSK Investigational Site
Seoul, Korea, Republic of, 07061
GSK Investigational Site
Seoul, Korea, Republic of, 134-727
GSK Investigational Site
Seoul, Korea, Republic of, 135-720
GSK Investigational Site
Seoul, Korea, Republic of, 150-713
GSK Investigational Site
Seoul, Korea, Republic of, 158-710
GSK Investigational Site
Seoul, Korea, Republic of, 05030
GSK Investigational Site
Seoul, Korea, Republic of, 05355
GSK Investigational Site
Seoul, Korea, Republic of, 07441
GSK Investigational Site
Suwon, Korea, Republic of, 442-723
GSK Investigational Site
Uijeongbu-si, Korea, Republic of, 11765
GSK Investigational Site
Wonju-si, Korea, Republic of, 26426
Malaysia
GSK Investigational Site
Batu Caves, Malaysia, 68100
GSK Investigational Site
Ipoh, Malaysia, 30990
GSK Investigational Site
Johor Bahru, Malaysia, 80100
GSK Investigational Site
Kuala Lumpur, Malaysia, 50603
GSK Investigational Site
Penang, Malaysia, 10990
GSK Investigational Site
Temerloh, Malaysia, 28000
Mexico
GSK Investigational Site
Saltillo, Coahuila, Mexico, CP 25230
GSK Investigational Site
Durango., Durango, Mexico, 34000
GSK Investigational Site
Ciudad De México, Estado De México, Mexico, 14000
GSK Investigational Site
Cuautitlan Izcalli, Estado De México, Mexico, 54769
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44620
GSK Investigational Site
Queretaro, Querétaro, Mexico, 76000
GSK Investigational Site
Merida, Yucatán, Mexico, 97070
GSK Investigational Site
Aguascalientes, Mexico, 20230
GSK Investigational Site
Chihuahua, Mexico, 31203
GSK Investigational Site
Chihuahua, Mexico, 31217
GSK Investigational Site
Guadalajara, Mexico, 44600
GSK Investigational Site
México, D.F., Mexico, 14080
GSK Investigational Site
Zapopan, Jalisco, Mexico, 45030
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Deventer, Netherlands, 7416 SE
GSK Investigational Site
Rotterdam, Netherlands, 3079 DZ
New Zealand
GSK Investigational Site
Hamilton, New Zealand, 2001
GSK Investigational Site
Hastings, New Zealand
GSK Investigational Site
Otahuhu, New Zealand, 1640
Norway
GSK Investigational Site
Oslo, Norway, 0405
GSK Investigational Site
Stavanger, Norway, 4011
Poland
GSK Investigational Site
Biala Podlaska, Poland, 21-500
GSK Investigational Site
Gdansk, Poland, 80-462
GSK Investigational Site
Grojec, Poland, 05-600
GSK Investigational Site
Kielce, Poland, 25-736
GSK Investigational Site
Kolobrzeg, Poland, 78-100
GSK Investigational Site
Kolo, Poland, 62-600
GSK Investigational Site
Lodz, Poland, 90-262
GSK Investigational Site
Lodz, Poland, 92-213
GSK Investigational Site
Olkusz, Poland, 32-300
GSK Investigational Site
Pruszkow, Poland, 05-800
GSK Investigational Site
Tomaszow Mazowiecki, Poland, 97-200
GSK Investigational Site
Warszawa, Poland, 02-758
GSK Investigational Site
Zary, Poland, 68-200
Portugal
GSK Investigational Site
Amadora, Portugal, 2700-391
GSK Investigational Site
Corroios., Portugal, 2855227
GSK Investigational Site
Covilhã, Portugal, 6200-000
GSK Investigational Site
Forte Da Casa, Portugal, 2625-437
GSK Investigational Site
Lisboa, Portugal, 1069-166
GSK Investigational Site
Lisboa, Portugal, 1250-203
GSK Investigational Site
Lisboa, Portugal, 1400-195
GSK Investigational Site
Lisboa, Portugal, 1750-130
GSK Investigational Site
Mirandela, Portugal, 5370-530
GSK Investigational Site
Portimão, Portugal, 8500-311
GSK Investigational Site
Vila Franca de Xira, Portugal, 2600-076
GSK Investigational Site
Vila Real (Lordelo), Portugal, 5000-668
Romania
GSK Investigational Site
Arad, Romania, 310141
GSK Investigational Site
Bucharest, Romania, 022328
GSK Investigational Site
Resita, Romania, 320166
GSK Investigational Site
Targu Jiu, Romania, 210146
Russian Federation
GSK Investigational Site
Irkutsk, Russian Federation, 664049
GSK Investigational Site
Krasnodar, Russian Federation, 350029
GSK Investigational Site
Mytischi, Russian Federation, 141009
GSK Investigational Site
Nizhniy Novgorod, Russian Federation, 603126
GSK Investigational Site
Novosibirsk, Russian Federation, 630087
GSK Investigational Site
Omsk, Russian Federation, 644112
GSK Investigational Site
Orenburg, Russian Federation, 460040
GSK Investigational Site
Penza, Russian Federation, 440034
GSK Investigational Site
St-Petersburg, Russian Federation, 197110
GSK Investigational Site
St. Petersburg, Russian Federation, 191104
GSK Investigational Site
St. Petersburg, Russian Federation, 194354
GSK Investigational Site
St. Petersburg, Russian Federation, 196247
GSK Investigational Site
Volzhsky, Russian Federation, 404120
GSK Investigational Site
Yaroslavl, Russian Federation, 150062
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 169608
GSK Investigational Site
Singapore, Singapore, 308433
South Africa
GSK Investigational Site
Cape Town., South Africa, 7925
GSK Investigational Site
Cape Town, South Africa, 7500
Spain
GSK Investigational Site
Majadahonda, Madrid, Spain, 28222
GSK Investigational Site
Alcala de Henares, Spain, 28805
GSK Investigational Site
Aranda de Duero, Spain, 09400
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Badalona, Spain, 08036
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Ciudad Real, Spain, 13005
GSK Investigational Site
Girona, Spain, 17007
GSK Investigational Site
Guadalajara, Spain, 19002
GSK Investigational Site
Madrid, Spain, 28007
GSK Investigational Site
Madrid, Spain, 28020
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Manises (Valencia), Spain, 46940
GSK Investigational Site
Mollet del Valles, Spain, 08100
GSK Investigational Site
Málaga, Spain, 29530
GSK Investigational Site
Palma de Mallorca, Spain, 07120
GSK Investigational Site
Sabadell, Spain, 08208
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Valladolid, Spain, 47005
Sweden
GSK Investigational Site
Stockholm, Sweden, SE-141 86
GSK Investigational Site
Stockholm, Sweden, SE-182 88
GSK Investigational Site
Uppsala, Sweden
GSK Investigational Site
Örebro, Sweden, SE-701 85
Taiwan
GSK Investigational Site
Kaohsiung, Taiwan, 807
GSK Investigational Site
Kaohsiung, Taiwan, 83301
GSK Investigational Site
Keelung, Taiwan, 204
GSK Investigational Site
New Taipei City, Taiwan, 23561
GSK Investigational Site
New Taipei City, Taiwan, 237
GSK Investigational Site
New Taipei, Taiwan, 220
GSK Investigational Site
Tainan, Taiwan, 704
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei, Taiwan, 116
GSK Investigational Site
Taoyuan Hsien, Taiwan, 333
GSK Investigational Site
Zhongzheng Dist., Taipei, Taiwan, 10002
Turkey
GSK Investigational Site
Adana, Turkey, 01330
GSK Investigational Site
Ankara, Turkey, 06100
GSK Investigational Site
Antalya, Turkey, 07059
GSK Investigational Site
Edirne, Turkey, 22030
GSK Investigational Site
Eskisehir, Turkey, 26480
GSK Investigational Site
Kayseri, Turkey, 38039
Ukraine
GSK Investigational Site
Chernihiv, Ukraine, 14029
GSK Investigational Site
Chernivtsi, Ukraine, 58005
GSK Investigational Site
Ivano-Frankivsk, Ukraine, 76008
GSK Investigational Site
Kherson, Ukraine, 73039
GSK Investigational Site
Kiev, Ukraine, 04107
GSK Investigational Site
Kyiv, Ukraine
GSK Investigational Site
Kyiv, Ukraine, 01023
GSK Investigational Site
Kyiv, Ukraine, 04050
GSK Investigational Site
Mykolaiv, Ukraine, 54058
GSK Investigational Site
Ternopil, Ukraine, 46002
GSK Investigational Site
Zaporizhzhia, Ukraine, 69001
GSK Investigational Site
Zaporizhzhia, Ukraine, 69600
GSK Investigational Site
Zhytomyr, Ukraine, 10002
United Kingdom
GSK Investigational Site
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
GSK Investigational Site
Preston, Lancashire, United Kingdom, PR2 9HT
GSK Investigational Site
Wolverhampton, West Midlands, United Kingdom, WV10 0QP
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
GSK Investigational Site
Derby, United Kingdom, DE22 3NE
GSK Investigational Site
Doncaster, United Kingdom, DN2 5LT
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
GSK Investigational Site
Fife, United Kingdom, KY2 5AH
GSK Investigational Site
Glasgow, United Kingdom, G51 4TF
GSK Investigational Site
Hull, United Kingdom, HU3 2JZ
GSK Investigational Site
London, United Kingdom, E1 1BB
GSK Investigational Site
London, United Kingdom, SE5 9RS
GSK Investigational Site
Oxford, United Kingdom, OX3 7LE
GSK Investigational Site
Salford, United Kingdom, M6 8HD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02879305    
Other Study ID Numbers: 200807
2016-000541-31 ( EudraCT Number )
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
erythropoiesis stimulating agents
GSK1278863
daprodustat
anemia
chronic kidney disease
hemoglobin
recombinant human erythropoietin
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics