Trials / Completed
CompletedNCT04410198
Study of Roxadustat Conversion in Participants Receiving Stable Erythropoiesis-Stimulating Agent (ESA) or as Initial Anemia Treatment in Chronic Dialysis Participants
A Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From a Continuous Erythropoietin Receptor Activator (CERA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients - DENALI Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Kyntra Bio · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and effectiveness of Roxadustat dosing regimens among chronic dialysis participants converted from ESA therapy or who are ESA-naïve.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Roxadustat | Roxadustat will be administered per dose and schedule specified in the arm description. |
Timeline
- Start date
- 2020-05-26
- Primary completion
- 2021-06-30
- Completion
- 2021-10-11
- First posted
- 2020-06-01
- Last updated
- 2022-09-13
- Results posted
- 2022-09-13
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04410198. Inclusion in this directory is not an endorsement.