NCT03329196

Efficacy and Safety Study to Evaluate MT-6548 in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

A Phase III, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

For Non-dialysis subjects with anemia associated with chronic kidney disease, demonstrate non-inferiority of MT-6548 compared to darbepoetin alfa using Hb value and evaluate long-term safety of MT-6548. For subjects not currently receiving ESAs, evaluate Hb correction and maintenance effect of MT-6548 and for subjects currently receiving ESAs, evaluate Hb conversion and maintenance effect of MT-6548

Conditions

• Anemia; Non-dialysis Dependent Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	MT-6548	Oral tablet
DRUG	Darbepoetin alfa	Subcutaneous

Timeline

• Start date: 2017-10-30
• Primary completion: 2019-01-08
• Completion: 2019-08-09
• First posted: 2017-11-01
• Last updated: 2026-04-06
• Results posted: 2021-04-12

Locations

31 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study