Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects... | NCT03409107 | Trialant

Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects... | NCT03409107 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

>=18 years of age at the time of signing the informed consent.

Have CKD, confirmed at screening: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by Estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.

Participants with Stable HemoCue Hgb from 8.5 to 10.5 at screening visit (Week -4) and from 8.5 to 10.0 g/dL at randomization (Day 1).

Participants may receive up to one intravenous (IV) iron dose within the 8 weeks prior to screening and NO IV iron use between screening visit and randomization (Day 1).

If needed, participant may be on stable maintenance oral iron supplementation. There should be <50% change in overall dose and no change in type of iron prescribed in the 4 weeks prior to Day 1 randomization visit.

Male and female participants are eligible. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) or WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 weeks after the last dose of study treatment.

Capable of giving signed informed consent.

Exclusion Criteria:

Participants who are on dialysis or clinical evidence of impending need to initiate dialysis within 180 days after randomization (Day 1).

Planned living-related or living-unrelated kidney transplant within 28 weeks after randomization (Day 1).

Transferrin saturation (TSAT) <15 percent (Screening only).

Ferritin <50 nanograms per milliliter (ng/mL) (Screening only).

History of rhEPO or rhEPO analogue use within the 8 weeks prior to screening and rhEPO use between screening and randomization (Day 1).

History of transfusion within the 8 weeks prior to screening and transfusion between screening and randomization (Day 1).

History of bone marrow aplasia or pure red cell aplasia (PRCA).

Participants with Megaloblastic anemia (untreated pernicious anemia and folate deficiency), thalassemia major, sickle cell disease or myelodysplastic syndrome.

Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant gastrointestinal (GI) bleeding <= 8 weeks prior to screening through to randomization (Day 1).

History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.

Use of strong inhibitor of CYP2C8 (for example, gemfibrozil) or strong inducers of CYP2C8 (for example, rifampin/rifampicin).

Ferric citrate use within 4 weeks prior to randomization (Day 1).

Use of other investigational agent or device prior to screening through to randomization (Day 1).

Any prior treatment with daprodustat for a treatment duration of >30 days.

MI or acute coronary syndrome within the 8 weeks prior to screening through to randomization. (Day 1).

Stroke or transient ischemic attack within the 8 weeks prior to screening through to randomization. (Day 1).

Chronic Class IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.

QT interval corrected by Bazett's formula (QTcB) >500 milliseconds (msec) or QTcB >530 msec in participants with bundle branch block. There is no corrected QT interval (QTc) exclusion for participants with a predominantly paced rhythm.

Alanine transaminase (ALT) >2x upper limit of normal (ULN) at screening (Week -4).

Bilirubin >1.5xULN at screening (Week -4).

Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.

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 (for example, Bosniak Category II F, III or IV) > 3 centimeters (cm).

Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the participant at unacceptable risk, which may affect study compliance or prevent understanding of the aims or investigational procedures or possible consequences of the study.

Current uncontrolled hypertension as determined by the investigator.

GSK Investigational Site

Homewood, Alabama 35209, United States

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Little Rock, Arkansas 72204, United States

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Downey, California 90242, United States

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Fresno, California 93720, United States

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Lynwood, California 90262, United States

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Northridge, California 91324, United States

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Northridge, California 91325, United States

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Riverside, California 82503, United States

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Salinas, California 93901, United States

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Santa Ana, California 92704, United States

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Denver, Colorado 80230, United States

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Hartford, Connecticut 06112, United States

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Middlebury, Connecticut 06762, United States

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Coral Springs, Florida 33067, United States

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Hollywood, Florida 33024, United States

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Kissimmee, Florida 34741, United States

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Lauderdale Lakes, Florida 33313, United States

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Pembroke Pines, Florida 33028, United States

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Tampa, Florida 33614, United States

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Adairsville, Georgia 30103, United States

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Macon, Georgia 31201, United States

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Macon, Georgia 31217, United States

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Statesboro, Georgia 30458, United States

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Indianapolis, Indiana 46260, United States

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Overland Park, Kansas 66210, United States

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Buckley, Michigan 49620, United States

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Detroit, Michigan 48202, United States

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Saint Clair Shores, Michigan 48081, United States

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Brookhaven, Mississippi 39601, United States

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St Louis, Missouri 63136, United States

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Rochester, New Hampshire 03867, United States

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Asheville, North Carolina 28801, United States

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Charlotte, North Carolina 28262, United States

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Durham, North Carolina 27704, United States

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Midwest City, Oklahoma 73130, United States

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Oklahoma City, Oklahoma 73112, United States

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Beaver, Pennsylvania 15009, United States

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Duncansville, Pennsylvania 16635, United States

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Scottdale, Pennsylvania 15683, United States

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Smithfield, Pennsylvania 15478, United States

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West Reading, Pennsylvania 19611, United States

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Orangeburg, South Carolina 29118, United States

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Kingsport, Tennessee 37660, United States

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Memphis, Tennessee 38163, United States

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DeSoto, Texas 75115, United States

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El Paso, Texas 79935, United States

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McAllen, Texas 78503, United States

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Waxahachie, Texas 75165, United States

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Norfolk, Virginia 23502, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires C1128AAF, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires C1425AGC, Argentina

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Mar del Plata, Buenos Aires 7600, Argentina

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Mar del Plata, Buenos Aires B7600FZN, Argentina

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San Nicolás de los Arroyos, Buenos Aires B2900DMH, Argentina

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Córdoba, Córdoba Province 5003, Argentina

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Rosario, Santa Fe Province S2000DEJ, Argentina

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Santa Fe, 3000, Argentina

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Sydney, New South Wales 2010, Australia

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Heidelberg, Victoria 3084, Australia

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Parkville, Victoria 3050, Australia

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Murdoch, Western Australia 6150, Australia

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Fitzroy, 3065, Australia

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Vitória, Espírito Santo 29055450, Brazil

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Feira de Santana, Estado de Bahia 44001-584, Brazil

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Salvador, Estado de Bahia 40415-065, Brazil

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Ribeirão Preto, São Paulo 14025170, Brazil

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Santo André - SP, São Paulo 09080-110, Brazil

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São Bernardo do Campo, São Paulo 09715090, Brazil

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São José do Rio Preto, São Paulo 15015200, Brazil

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São José do Rio Preto, São Paulo 15090-000, Brazil

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São Paulo, 04038002, Brazil

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Victoria, British Columbia V8V 4A1, Canada

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Brampton, Ontario L6T 0G1, Canada

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Greater Sudbury, Ontario P3A-1W8, Canada

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Guelph, Ontario N1H 1B1, Canada

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Kitchener, Ontario N2H 5Z8, Canada

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Ottawa, Ontario K1H 1A2, Canada

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Sarnia, Ontario N7T 4X3, Canada

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Toronto, Ontario M5B 1W8, Canada

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Toronto, Ontario M9N 1N8, Canada

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Toronto, Ontario M9V 4B4, Canada

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Montreal, Quebec H1M 1B1, Canada

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Québec, Quebec G2J 0C4, Canada

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Québec, Quebec G3K 2P8, Canada

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Saint-Charles-Borromée, Quebec J6E 2B4, Canada

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Grenoble, 38043, France

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Le Mans, 72037, France

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Marseille, 13385, France

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Melun, 77000, France

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Mulhouse, 68070, France

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Nantes, 44093, France

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Nice, 06001, France

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Saint-Priest-en-Jarez, 42270, France

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Catanzaro, Calabria 88100, Italy

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Naples, Campania 80131, Italy

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Bologna, Emilia-Romagna 40138, Italy

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Modena, Emilia-Romagna 41124, Italy

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Genoa, Liguria 16132, Italy

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Pavia, Lombardy 27100, Italy

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Mestre, Veneto 30174, Italy

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León, Guanajuato 37530, Mexico

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Guadalajara, Jalisco 44150, Mexico

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Monterrey, Nuevo León 64060, Mexico

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Boca del Rio, Veracruz 24290, Mexico

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Córdoba, Veracruz 94550, Mexico

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Mérida, Yucatán 97070, Mexico

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Guadalajara, 44600, Mexico

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Mérida, 97000, Mexico

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Veracruz, 91900, Mexico

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Bialystok, 15-276, Poland

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Ciechanów, 06-400, Poland

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Krakow, 30510, Poland

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Krakow, 31-513, Poland

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Krakow, 31-559, Poland

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Lodz, 92-213, Poland

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Lublin, 20-064, Poland

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Oława, 55-200, Poland

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Pleszew, 63-300, Poland

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Sosnowiec, 41-200, Poland

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Szczecin, 70-111, Poland

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Świdnik, 21-040, Poland

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Tczew, 83-110, Poland

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Warsaw, 01-868, Poland

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Warsaw, 02-801, Poland

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Warsaw, 04-749, Poland

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Brasov, 500283, Romania

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Bucharest, 022328, Romania

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Bucharest, 042122, Romania

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Cluj-Napoca, 400139, Romania

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Craiova, 200642, Romania

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Deva, 330084, Romania

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Oradea, 410469, Romania

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Târgu Mureş, 540096, Romania

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Timișoara, 300723, Romania

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Izhevsk, 426061, Russia

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Kaliningrad, 236016, Russia

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Kemerovo, 650066, Russia

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Krasnoyarsk, 660022, Russia

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Moscow, 121359, Russia

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Nizhny Novgorod, 603126, Russia

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Pyatigorsk, 357500, Russia

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Pyatigorsk, 357538, Russia

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Rostov-on-Don, 344022, Russia

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Ryazan, 390037, Russia

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Saint Petersburg, 194355, Russia

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Saint Petersburg, 197022, Russia

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Stavropol, 355017, Russia

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Yaroslavl, 150000, Russia

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Yaroslavl, 150030, Russia

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Yaroslavl, 150062, Russia

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Busan, 49201, South Korea

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Busan, 49241, South Korea

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Daegu, 42415, South Korea

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Daegu, 42601, South Korea

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Gyeonggi-do, 463-712, South Korea

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Seongnam-si, Gyeonggi-do, 13620, South Korea

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Seoul, 03312, South Korea

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Seoul, 08308, South Korea

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Badalona, 08916, Spain

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Madrid, 28040, Spain

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Santiago de Compostela, 15890, Spain

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Canterbury, Kent CT1 3NG, United Kingdom

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Derby, DE22 3NE, United Kingdom

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London, SE5 9RS, United Kingdom

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Peterborough, PE3 9GZ, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Shrewsbury, SY3 8XQ, United Kingdom

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Swansea, SA6 6NL, United Kingdom