At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 323 enrolled
Drug / intervention
MT-6548 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating MT-6548, Darbepoetin alfa, and 2 other interventions for Anemia; Hemodialysis Dependent Chronic Kidney Disease. Completed, enrolled 323 participants across 28 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartFeb 2018
First PostedFeb 2018
Primary CompletionDec 2018
Study CompletionJul 2019
TodayJul 2026
First PostedFeb 20, 2018
Enrollment StartFeb 14, 2018
Primary CompletionDec 12, 2018
Study CompletionJul 16, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.4 years ago
Interventions
MT-6548drug
Oral tablet
Darbepoetin alfadrug
Intravenous administration
MT-6548-matching placebodrug
Oral tablet
Darbepoetin alfa-matching placebodrug
Intravenous administration