Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07119372

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

Led by Biocad · Updated on 2025-08-13

228

Participants Needed

2

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form for participation in the study
  • Men and women aged 18 to 75 years inclusive at the time of signing the informed consent
  • Documented end-stage kidney disease
  • Receiving dialysis sessions at least 3 times a week for a total of at least 12 hours per week for at least 90 days before signing informed consent
  • Documented use of recombinant erythropoietin for at least 90 days before signing informed consent
  • Stable dose of recombinant erythropoietins for at least 90 days before signing informed consent and throughout the screening period
  • Target hemoglobin level between 100 and 120 g/L based on two screening measurements
  • Established dialysis efficacy at screening (Kt/v ≥1.2 for hemodialysis or weekly Kt/v ≥1.7 for peritoneal dialysis)
  • Transferrin saturation ≥20% and ferritin level >100 ng/mL at screening
  • Vitamin B12 and folic acid levels within normal laboratory reference values at screening
  • Willingness to use contraception during the study and for 90 days after last dose
  • Ability to comply with the study protocol as judged by the investigator
Not Eligible

You will not qualify if you...

  • Any anemia causes other than anemia of renal disease, including anemia of chronic diseases (C-reactive protein >20 mg/L)
  • Diagnosed lupus nephritis or chronic kidney disease from systemic vasculitis
  • Platelet count less than 100×10⁹/L at screening
  • Planned kidney transplant surgery during study participation
  • History of severe allergic reactions or hypersensitivity to study drugs or iron (III) hydroxide sucrose complex
  • Vaccination less than 8 weeks before signing informed consent
  • Diagnosed liver cirrhosis
  • HIV infection
  • ALT or AST levels more than three times upper limit of normal at screening
  • Decompensated heart disease (NYHA Class IV CHF)
  • Resistant hypertension
  • Unstable angina
  • History of acute hemolysis episodes
  • Documented hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, or pure red cell aplasia
  • Severe secondary hyperparathyroidism or bone marrow fibrosis
  • Recent gastrointestinal or other bleeding within 90 days before signing informed consent
  • Recent thrombosis episodes within 6 months or vascular access thrombosis within 30 days before signing informed consent
  • Seizure syndrome or epilepsy during screening period
  • Major surgery less than 30 days before signing informed consent
  • Blood transfusion within 90 days prior to signing informed consent
  • Acute or chronic infections in exacerbation or other chronic diseases affecting safety
  • History of severe depression, suicidal ideation, or suicide attempts
  • Malignancies other than cured basal-cell carcinoma or cervical carcinoma in situ with remission over 5 years
  • Known or current alcohol or drug addiction limiting treatment adherence
  • Participation in other clinical drug studies within 90 days prior to informed consent
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Minsk Scientific and Practical Center for Surgery, Transplantology and Hematology

Minsk, Belarus, 220045

Actively Recruiting

2

B. Braun Avitum Russland Clinics Ltd.

Saint Petersburg, Russia, 199004

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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