Trials / Completed
CompletedNCT03400033
Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 407 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daprodustat tablets | Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route. |
| DRUG | Matching placebo tablets | Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route. |
| DRUG | Epoetin alfa vials | Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route. |
| DRUG | Saline vials or bags | 0.9% sodium chloride saline vials or bags administered by the IV route. |
Timeline
- Start date
- 2018-09-05
- Primary completion
- 2020-06-19
- Completion
- 2020-06-19
- First posted
- 2018-01-17
- Last updated
- 2021-07-12
- Results posted
- 2021-07-12
Locations
91 sites across 13 countries: United States, Argentina, Australia, Brazil, Canada, France, Italy, Poland, Romania, Russia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03400033. Inclusion in this directory is not an endorsement.