NCT03543657

Maintenance Treatment of Renal Anemia in Dialysis Subjects

A Randomized, Active-controlled, Double-blinded, Double-dummy, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Dialysis Subjects Treated With Erythropoiesis-Stimulating Agents (ESAs)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 229 (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 comparison to darbepoetin alfa in dialysis subjects with renal anemia who are treated with Erythropoiesis-Stimulating Agents (ESAs).

Conditions

• Anemia
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Molidustat (BAY85-3934)	Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).
DRUG	Darbepoetin alfa	Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.
DRUG	Placebo of Molidustat (BAY85-3934)	Matching placebo of Molidustat.
DRUG	Placebo of Darbepoetin alfa	Matching placebo of Darbepoetin alfa.

Timeline

• Start date: 2018-06-23
• Primary completion: 2019-08-07
• Completion: 2019-12-24
• First posted: 2018-06-01
• Last updated: 2021-01-29

Locations

53 sites across 1 country: Japan