Trials / Completed
CompletedNCT03350347
A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects
A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 164 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Molidustat (BAY85-3934) | Starting dose of 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response |
| DRUG | Darbepoetin alfa | Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response |
Timeline
- Start date
- 2017-12-13
- Primary completion
- 2019-07-05
- Completion
- 2019-11-28
- First posted
- 2017-11-22
- Last updated
- 2021-01-29
Locations
59 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03350347. Inclusion in this directory is not an endorsement.