Trials / Completed
CompletedNCT04484857
Study of Roxadustat Conversion in Participants Receiving Stable ESA or as Initial Anemia Treatment in Hemodialysis Participants
Phase 3b Multicenter, Open-Label Single Arm Study of Roxadustat: Either as Conversion From an Erythropoiesis Stimulating Agent (ESA), or as Initial Anemia Treatment in Hemodialysis (HD) Patients
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 283 (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 hemodialysis participants converted from erythropoiesis stimulating agent (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
- 2020-07-22
- Primary completion
- 2021-07-09
- Completion
- 2021-09-17
- First posted
- 2020-07-24
- Last updated
- 2022-07-26
- Results posted
- 2022-07-26
Locations
26 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04484857. Inclusion in this directory is not an endorsement.