2026-08-28
notable
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Enrollment closed, study ongoing
Trial sites expanded: 2 → 14 locations
Completion pushed: 2026-11 → 2027-10
Primary completion dateestimated 2026-05→confirmed 2026-05-12
Eligibility criteria+1 characters
[...] ney disease due to systemic vasculitis.
Platelet count <100×10910^9/L based on the results of screening examination.
A high pro [...]
Secondary endpoints17 entries, revised
Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive) during the last month of therapy
Study description+42 characters
This clinical study is baseddesigned onto test the hypothesis that BCD-131 is non-inferior to Mircera when used for the treatment of anemia in dialysis patients with end-stage CKDrenal afterdisease on dialysis, with the primary assessment occurring at Weeks 28-32 weeks of therapytreatment.
The study is intended to includeEligible subjects withwill stagehave Stage 5 Chronic Kidney Disease (CKD,) and will have been receiving dialysis for at least 90 days before signing the ICF (for patients on hemodialysis - a leastminimum frequency of 3 timessessions per week and at least 12 hours per week of s [...] [...]