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Tests treatment safety and results for Anemia
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
ClinicalTrials.gov ID: NCT07119372
What this study is testing
What is BCD-131 (pegdarbepoetin beta)?
BCD-131 (pegdarbepoetin beta) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join 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...
- Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.
- Platelet count \<100×109/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...
- A history of severe allergic reactions (anaphylactic shock or multiple drug allergy) according to the patient, and hypersensitivity to recombinant...
- Vaccination less than 8 weeks before signing the ICF (according to the patient).
See the full eligibility criteria
- 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...
- Target hemoglobin level (100-120 g/L inclusive) based on the results of screening examination (two measurements).
- The how well it works 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...
- 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...
- The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.
- 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 \<100×109/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...
- 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...
- 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).
- Documented episodes of gastrointestinal or other bleeding within less than 90 days prior to signing the ICF.
- Documented history of episodes of thrombosis (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary thromboembolism within less than 6 months before the signing of the ICF, as...
- Seizure syndrome, including a history of or epilepsy during the screening period.
- Documented major surgery less than 30 days before signing the ICF.
- Documented blood transfusion within less than 90 days prior to signing the ICF.
- Any acute or chronic infections in the stage of exacerbation, as well as other chronic diseases that at the time of signing the informed consent, may adversely affect the patient's safety while using the study therapy...
- A history of severe depression, suicidal ideation, or attempted suicide.
- Documented malignancies other than cured basal-cell carcinoma and/or cervical carcinoma in situ with a remission duration of more than 5 years at the time of signing the ICF.
- Known alcohol or drug addiction, or current signs of alcohol/drug addiction, which, according to the investigator, is contraindication for the treatment with the test drug/reference drug or limits the treatment...
- Participation in other clinical studies of medicinal products within less than 90 calendar days prior to signing the informed consent form for participation in this study.
- Pregnancy or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Minsk, Belarus
- Saint Petersburg, Russia
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minsk, Belarus; Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.