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 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: BCD-131-3
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 14

Brief 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

Anemia; Chronic Kidney Disease; Chronic Kidney Disease Patients on Hemodialysis; Chronic Kidney Disease 5D

Keywords

Chronic Kidney Disease; CKD; Anemia; Erythropoietin; Darbepoetin; Erythropoiesis-stimulating agent; Dialysis; Hemodialysis; Renal anemia

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive)

  During the assessment period at Weeks 28-32

Secondary Outcomes (17)

• Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive)

  Weeks 48-52

• Proportion of subjects (%) with a mean hemoglobin level at the time of assessment within the range of ±10 g/L from baseline

  Weeks 28-32

• Proportion of subjects (%) who required dose adjustment of the test drug/reference drug during the maintenance therapy stage of the main study period

  Weeks 12-32

• Proportion of subjects (%) who required dose adjustment of the test drug/reference drug during the extension study period

  Weeks 33-52

• Proportion of subjects (%) who required blood transfusion during the main study period

  Weeks 0-32

Other Outcomes (5)

• Proportion of subjects (%) with the target hemoglobin level (100-120 g/L inclusive)

  Weeks 80-84

• Proportion of subjects (%) who required dose adjustment of the investigational product after switching from Mircera to BCD-131

  Weeks 64-84

• Proportion of subjects (%) who required blood transfusion after switching from Mircera to BCD-131

  Weeks 52-84

Study Arms (2)

BCD-131

EXPERIMENTAL

BCD-131 (pegdarbepoetin beta)

Biological: BCD-131 (pegdarbepoetin beta)

Mircera

ACTIVE COMPARATOR

Mircera (methoxypolyethylene glycol-epoetin beta)

Biological: Mircera (methoxypolyethylene glycol-epoetin beta)

Interventions

BCD-131 (pegdarbepoetin beta) BIOLOGICAL

BCD-131 (pegdarbepoetin beta), subcutaneous injection; regimen: once every 4 weeks; therapy duration: 84 weeks

BCD-131

Mircera (methoxypolyethylene glycol-epoetin beta) BIOLOGICAL

Mircera (methoxypolyethylene glycol-epoetin beta), subcutaneous injection; regimen: once every 4 weeks up to Week 48 inclusive; starting from Week 52, all subjects will be switched to BCD-131 treatment up to Week 84 inclusive.

Mircera

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient signed a written ICF for participation in the study.
• Men and women aged 18 to 75 years inclusive at the time of signing the ICF.
• End stage kidney disease (documented).
• The need for dialysis sessions within at least the last 90 days prior to signing the ICF.
• For patients on hemodialysis - hemodialysis procedures should be at least 3 times a week, for a total duration of at least 12 hours a week.
• Documented use of recombinant erythropoietin (epoetin alfa, epoetin beta or darbepoetin alfa) for at least 90 days prior to signing the ICF.
• The dose of recombinant erythropoietins (epoetin alfa or epoetin beta received 1, 2 or 3 times a week, or darbepoetin alfa received once a week/once every 2 weeks) should be stable for at least 90 days prior to signing the ICF and the entire screening period (documented).
• Target hemoglobin level (100-120 g/L inclusive) based on the results of screening examination (two measurements).
• The efficacy of dialysis established at screening or not more than 14 days before signing the ICF (dialysis dose index (Kt/v) ≥1.2 in patients on long-term hemodialysis, and weekly Kt/v ≥1.7 for patients on peritoneal dialysis).
• Transferrin saturation ≥20%, ferritin level \>100 ng/mL at screening.
• Cyancobalamine (vitamin B12) and folic acid levels within the laboratory reference values at screening.
• Willingness of patients of both sexes and their sexual partners of childbearing potential to use methods of contraception in accordance with the protocol, starting from signing the informed consent form, throughout the study and for up to 90 days after receiving the last dose of the drug in the clinical study, as well as to refrain from donation of eggs for female subjects or sperm for male subjects during this period.
• The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.

You may not qualify if:

• Any other diagnosed forms of anemia, except for anemia of renal disease, including anemia in chronic diseases (C-reactive protein level \>20 mg/L at screening).
• Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.
• Platelet count \<100×10\^9/L based on the results of screening examination.
• A high probability of early withdrawal from the study, in particular a planned (i.e., available information about a planned date and/or a suitable donor) kidney transplant surgery during the estimated period of participation in the study.
• A history of severe allergic reactions (anaphylactic shock or multiple drug allergy) according to the patient, and hypersensitivity to recombinant erythropoietins, polyethylene glycol or any components of the study drugs, or to iron (III) hydroxide sucrose complex.
• Vaccination less than 8 weeks before signing the ICF (according to the patient).
• Diagnosed liver cirrhosis.
• HIV infection.
• ALT, AST \>3хULN at screening.
• Decompensated heart disease (NYHA Class IV CHF).
• Resistant hypertension.
• Unstable angina.
• History of acute hemolysis episodes.
• Documented hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, pure red cell aplasia.
• Severe secondary hyperparathyroidism (intact PTH\>1000 pg/mL at screening) or biopsy-confirmed bone marrow fibrosis (myelofibrosis).

Sponsors & Collaborators

• Biocad: lead

Study Sites (14)

Limited Liability Company "Medical Center "NEFROS"

Krasnodar, Russia

Location

Limited Liability Company Medical Center "NEPHROS"

Krasnodar, Russia

Location

Limited Liability Company "Nephroline-Sibir"

Novosibirsk, Russia

Location

State Autonomous Healthcare Institution Orenburg Regional Clinical Center of Surgery and Traumatology

Orenburg, Russia

Location

"All-Russian Center for Emergency and Radiation Medicine named after A.M. Nikiforov" of the Ministry of Emergency Situations of the Russian Federation

Saint Petersburg, Russia

Location

Limited Liability Company "Kupchinsky Outpatient Dialysis Center"

Saint Petersburg, Russia

Location

Moscow Multidisciplinary Scientific and Clinical Center named after S.P. Botkin

Saint Petersburg, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "City Clinical Hospital No. 31"

Saint Petersburg, Russia

Location

Saint Petersburg State Budgetary Healthcare Institution "S.P. Botkin Clinical Infectious Diseases Hospital"

Saint Petersburg, Russia

Location

St. Petersburg City Hospital No. 26

Saint Petersburg, Russia

Location

State Budgetary Healthcare Institution "Volgograd Regional Uronephrological Center"

Volgograd, Russia

Location

Limited Liability Company "Medical Diagnostic Center"

Yaroslavl, Russia

Location

Limited Liability Company "FAMILY CLINIC"

Yekaterinburg, Russia

Location

Sverdlovsk Regional Clinical Hospital No. 1

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 13, 2025
• Study Start: March 1, 2025
• Primary Completion: May 12, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 1, 2026

Record last verified: 2025-08

Locations

RU (14)