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Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis

NCT07119372 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-08-13

No results posted yet for this study

Summary

BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.

Conditions

Interventions

BIOLOGICAL

BCD-131 (pegdarbepoetin beta)

BCD-131 (pegdarbepoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks

BIOLOGICAL

Mircera (methoxypolyethylene glycol-epoetin beta)

Mircera (methoxypolyethylene glycol-epoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 52 weeks

Sponsors & Collaborators

  • Biocad

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2026-05-31
Completion
2026-11-30

Countries

  • Belarus
  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119372 on ClinicalTrials.gov