BCD-131-3 "A randomized open-label comparative clinical trial of the efficacy and safety of BCD-131 and Myrcera® in the therapy of anemia in chronic renal failure patients on dialysis".
During the BCD-131-3 clinical trial, the efficacy and safety of the investigational drug BCD-131 and Myrcera® will be compared in the treatment of anemia in subjects with chronic renal failure on dialysis who:
Are 18–75 years of age inclusive at the time of signing the informed consent form.
Have a documented diagnosis of terminal renal failure.
Have a need for dialysis sessions for at least 90 days prior to signing the informed consent form. For potential study participants receiving hemodialysis, hemodialysis must be performed at least 3 times per week, totaling at least 12 hours per week.
Have documented use of a recombinant erythropoietin product (epoetin alfa, epoetin beta, or darbepoetin alfa) for at least 90 days prior to signing the informed consent form.
Have dialysis efficiency (dialysis dose index1 (Kt/v) ≥ 1.2 for potential participants receiving program hemodialysis2 and weekly Kt/v ≥ 1.7 for potential participants receiving peritoneal dialysis3) established at the screening examination or not more than 14 days prior to signing the informed consent form.
This clinical study has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical study); the full list will be provided to a potential participant by the Clinical Investigator. Among other factors, the non-inclusion criteria include the following:
Any other diagnosed forms of anemia, except renal anemia, including anemia in chronic disease (C-reactive protein level > 20 mg/L based on the results of an examination performed during the screening period4.
An established diagnosis of lupus nephritis or chronic kidney disease due to systemic vasculitis in a potential participant.
Severe secondary hyperparathyroidism (intact PTH5 1,000 pg/mL by examination performed during the screening period) or biopsy-confirmed bone marrow fibrosis (myelofibrosis).
Documented episodes of gastrointestinal or other bleeding less than 90 days prior to signing the informed consent form.
History of allergies.
History of documented episodes of thrombosis (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary embolism) less than 6 months prior to signing the informed consent form, as well as thrombosis of permanent vascular access less than 30 days prior to signing the informed consent form.
Documented hemotransfusion less than 90 days prior to signing the informed consent form.
The clinical trial of BCD-131-3 is being conducted in study centers in different cities of the Russian Federation, including Moscow, St. Petersburg, Yaroslavl, Krasnodar, Novorossiysk, Yekaterinburg, Orenburg, Novosibirsk, Gatchina, and Volzhsky (Volgograd Region).
To query about participating in a clinical trial, including contact details of study centers, please use special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications to participation in this clinical trial. The potential participant should read the complete study information and consult with the Physician Investigator and/or their Attending Physician.
Clinical Study Authorization No. 550 dated September 19, 2019 of the Ministry of Health of the Russian Federation and the list of approved study centers are published in the State Register of Medicines.
Dialysis dose index is the dialysis urea adequacy index, which is the ratio of blood clearance volume per one session: Kt/V, where K is the dialyzer's actual urea clearance (mL/min), t is the hemodialysis time (min), and V is the volume of urea distribution (mL), which is equal to approximately 60% of "dry" weight.
Program hemodialysis is a type of hemodialysis in which a patient undergoes dialysis continuously, according to an individually tailored program, with a pre-calculated "dry" weight (the patient's weight without excess fluid in the body).
Peritoneal dialysis is a type of dialysis that uses the peritoneum in a person's abdomen as the membrane through which fluid and dissolved substances are exchanged with the blood.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical study according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.
Parathyroid hormone (PTH) is a hormone that is synthesized by the parathyroid glands and plays an important role in regulating calcium and phosphorus levels in the body.