Conditions: Anemia; Hemodialysis Dependent Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 323
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: MT-6548 intervention 2: Darbepoetin alfa intervention 3: MT-6548-matching placebo intervention 4: Darbepoetin alfa-matching placebo
Intervention descriptions: intervention 1: Oral tablet intervention 2: Intravenous administration intervention 3: Oral tablet intervention 4: Intravenous administration

Protocol document:
Prot_000.pdf: 





























































































































































































































SAP_001.pdf: