At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 304 enrolled
Drug / intervention
MT-6548 +1 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, Open-label, Confirmatory Study of MT-6548 Compared to Darbepoetin Alfa in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease in Japan
In Brief
A Phase 3 clinical trial evaluating MT-6548 and Darbepoetin alfa for Anemia; Non-dialysis Dependent Chronic Kidney Disease. Completed, enrolled 304 participants across 31 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartOct 2017
First PostedNov 2017
Primary CompletionJan 2019
Study CompletionAug 2019
TodayJul 2026
First PostedNov 1, 2017
Enrollment StartOct 30, 2017
Primary CompletionJan 8, 2019
Study CompletionAug 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.7 years ago
Interventions
MT-6548drug
Oral tablet
Darbepoetin alfadrug
Subcutaneous