NCT01975818

Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934

A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels. Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits. Titration will be based on the subject's Hb response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day

Conditions

• Anemia
• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Molidustat (BAY 85-3934)	Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
BIOLOGICAL	Epoetin alfa/beta

Timeline

• Start date: 2013-10-28
• Primary completion: 2015-10-23
• Completion: 2015-12-15
• First posted: 2013-11-05
• Last updated: 2019-09-20

Locations

35 sites across 2 countries: United States, Japan