Conditions: Anemia; Non-dialysis Dependent Chronic Kidney Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: MT-6548 intervention 2: Darbepoetin alfa
Intervention descriptions: intervention 1: Oral tablet intervention 2: Subcutaneous

Protocol document:
Prot_000.pdf: 







































































































































































































SAP_001.pdf: