Trials / Completed
CompletedNCT02879305
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,964 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Daprodustat | Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range. |
| 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. |
Timeline
- Start date
- 2016-09-28
- Primary completion
- 2020-11-09
- Completion
- 2020-11-09
- First posted
- 2016-08-25
- Last updated
- 2021-12-03
- Results posted
- 2021-12-03
Locations
462 sites across 35 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Italy, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02879305. Inclusion in this directory is not an endorsement.