NCT03439137

Efficacy and Safety Study to Evaluate MT-6548 in Hemodialysis Subjects Currently Receiving ESAs With Anemia Associated With Chronic Kidney Disease in Japan

A Phase III, Double Blind, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

For hemodialysis subjects currently receiving ESAs 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.

Conditions

• Anemia; Hemodialysis Dependent Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	MT-6548	Oral tablet
DRUG	Darbepoetin alfa	Intravenous administration
DRUG	MT-6548-matching placebo	Oral tablet
DRUG	Darbepoetin alfa-matching placebo	Intravenous administration

Timeline

• Start date: 2018-02-14
• Primary completion: 2018-12-12
• Completion: 2019-07-16
• First posted: 2018-02-20
• Last updated: 2026-04-06
• Results posted: 2021-04-12

Locations

28 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study