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Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat in Non-Dialysis Subjects Evaluating Hemoglobin (Hgb) and Quality of Life (ASCEND-NHQ)

NCT ID: NCT03409107

Last Updated: 2024-04-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

614 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-05

Study Completion Date

2020-10-07

Brief Summary

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The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.

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Detailed Description

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Conditions

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Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to receive Daprodustat or placebo in a randomized manner.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
This will be a double-blind study. The participant, investigator, site staff, and study team will be blinded to the assigned study treatment.

Study Groups

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Daprodustat receivers

Participants will receive oral daprodustat once daily

Group Type EXPERIMENTAL

Daprodustat (GSK1278863)

Intervention Type DRUG

Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.

Iron therapy

Intervention Type DRUG

Iron therapy will be administered if ferritin is \<50 Nano gram per milliliter and/or TSAT is \<15 percent.

Placebo receivers

Participants will receive oral placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.

Iron therapy

Intervention Type DRUG

Iron therapy will be administered if ferritin is \<50 Nano gram per milliliter and/or TSAT is \<15 percent.

Interventions

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Daprodustat (GSK1278863)

Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.

Intervention Type DRUG

Placebo

Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.

Intervention Type DRUG

Iron therapy

Iron therapy will be administered if ferritin is \<50 Nano gram per milliliter and/or TSAT is \<15 percent.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Homewood, Alabama, United States

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Little Rock, Arkansas, United States

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Downey, California, United States

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Fresno, California, United States

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Lynwood, California, United States

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Northridge, California, United States

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Northridge, California, United States

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Riverside, California, United States

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Salinas, California, United States

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Santa Ana, California, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Middlebury, Connecticut, United States

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Coral Springs, Florida, United States

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Hollywood, Florida, United States

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Kissimmee, Florida, United States

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Lauderdale Lakes, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Adairsville, Georgia, United States

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Macon, Georgia, United States

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Macon, Georgia, United States

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Statesboro, Georgia, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Buckley, Michigan, United States

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Detroit, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Brookhaven, Mississippi, United States

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St Louis, Missouri, United States

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Rochester, New Hampshire, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Midwest City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Beaver, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Scottdale, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Orangeburg, South Carolina, United States

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Kingsport, Tennessee, United States

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Memphis, Tennessee, United States

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DeSoto, Texas, United States

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El Paso, Texas, United States

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McAllen, Texas, United States

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Waxahachie, Texas, United States

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Norfolk, Virginia, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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San Nicolás de los Arroyos, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Santa Fe, , Argentina

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Sydney, New South Wales, Australia

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Heidelberg, Victoria, Australia

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Parkville, Victoria, Australia

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Murdoch, Western Australia, Australia

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Fitzroy, , Australia

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Vitória, Espírito Santo, Brazil

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Feira de Santana, Estado de Bahia, Brazil

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Salvador, Estado de Bahia, Brazil

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Ribeirão Preto, São Paulo, Brazil

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Santo André - SP, São Paulo, Brazil

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São Bernardo do Campo, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, , Brazil

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Victoria, British Columbia, Canada

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Brampton, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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Guelph, Ontario, Canada

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Kitchener, Ontario, Canada

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Ottawa, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Saint-Charles-Borromée, Quebec, Canada

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Grenoble, , France

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Le Mans, , France

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Marseille, , France

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Melun, , France

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Mulhouse, , France

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Nantes, , France

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Nice, , France

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Saint-Priest-en-Jarez, , France

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Catanzaro, Calabria, Italy

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Napoli, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Modena, Emilia-Romagna, Italy

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Genoa, Liguria, Italy

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Pavia, Lombardy, Italy

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Mestre, Veneto, Italy

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León, Guanajuato, Mexico

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Guadalajara, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Boca del Rio, Veracruz, Mexico

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Córdoba, Veracruz, Mexico

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Mérida, Yucatán, Mexico

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Guadalajara, , Mexico

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Mérida, , Mexico

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Veracruz, , Mexico

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Bialystok, , Poland

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Ciechanów, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Oława, , Poland

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Pleszew, , Poland

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Sosnowiec, , Poland

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Szczecin, , Poland

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Świdnik, , Poland

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Tczew, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Brasov, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Craiova, , Romania

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Deva, , Romania

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Oradea, , Romania

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Târgu Mureş, , Romania

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Timișoara, , Romania

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Izhevsk, , Russia

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Kaliningrad, , Russia

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Kemerovo, , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Pyatigorsk, , Russia

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Pyatigorsk, , Russia

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Rostov-on-Don, , Russia

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Ryazan, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Stavropol, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Busan, , South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Gyeonggi-do, , South Korea

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Seongnam-si, Gyeonggi-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona, , Spain

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Madrid, , Spain

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Santiago de Compostela, , Spain

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Canterbury, Kent, United Kingdom

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Derby, , United Kingdom

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London, , United Kingdom

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Peterborough, , United Kingdom

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Plymouth, , United Kingdom

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Shrewsbury, , United Kingdom

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Swansea, , United Kingdom

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Countries

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United States Argentina Australia Brazil Canada France Italy Mexico Poland Romania Russia South Korea Spain United Kingdom

References

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Johansen KL, Cobitz AR, Singh AK, Macdougall IC, Lopes RD, Obrador GT, Kovesdy CP, Israni R, Jha V, Okoro T, Sprys M, Jolly S, Lindsay AC, Bhatt P, Camejo RR, Keeley T, Cizman B, Wheeler DC. The ASCEND-NHQ randomized trial found positive effects of daprodustat on hemoglobin and quality of life in patients with non-dialysis chronic kidney disease. Kidney Int. 2023 Jun;103(6):1180-1192. doi: 10.1016/j.kint.2023.02.019. Epub 2023 Mar 2.

Reference Type BACKGROUND
PMID: 36868377 (View on PubMed)

Natale 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.

Reference Type DERIVED
PMID: 36005278 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2017-002270-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205270

Identifier Type: -

Identifier Source: org_study_id

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