Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients

NCT ID: NCT02506868

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-08
• Study Completion Date: 2017-12-21

Brief Summary

The purpose of the study is to prove equivalence of efficacy and safety of BCD-066 and Aranesp® in treatment of anemia in end-stage chronic kidney disease patients on dialysis.

Detailed Description

In this study CKD patients on dialysis previously treated by short-acting epoetins will switch to one of darbepoetin alfa products - BCD-066 (experimental arm) or Aranesp (active comparator) to maintain previously achieved target level of hemoglobin (100-120 g/l).

Patients will be treated for 52 weeks. IV iron supplementation will be provided to maintain serum ferritin level above 500 µg/l according to KDIGO Anemia Guidelines (2012).

Conditions

Chronic Kidney Disease; End Stage Renal Failure on Dialysis; Anemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BCD-066

Patients in this arm will receive weekly subcutaneous injections of BCD-066 (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks

Group Type: EXPERIMENTAL

Darbepoetin alfa

Intervention Type: DRUG

Weekly sc administration of darbepoetin alfa

Aranesp

Patients in this arm will receive weekly subcutaneous injections of Aranesp (darbepoetin alfa) with dose level titration to maintain target hemoglobin level (100 - 120 g/l) for 52 weeks

Group Type: ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type: DRUG

Weekly sc administration of darbepoetin alfa

Interventions

Darbepoetin alfa

Weekly sc administration of darbepoetin alfa

Intervention Type: DRUG

Other Intervention Names

Aranesp; BCD-066

Eligibility Criteria

Inclusion Criteria

• Written informed consent
• Age between 18 and 75 years
• End-stage kidney disease
• Need for dialysis for at least 3 months before enrollment
• Need for at least 12 hours on standard dialysis procedure weekly
• Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3 times a week (stable dose, stable frequency) for at least 3 months before enrollment
• Target hemoglobin level (100-120 g/l) for at least 3 months before enrollment
• Effective dialysis (Kt/v≥1,2)
• TSAT ≥20%, Serum ferritin >200 ng/ml
• Patients and their sexual partners with childbearing potential must implement reliable contraceptive measures during all the study treatment, starting 4 weeks prior to the administration of the first dose of investigational product until 4 weeks after the last dose of investigational product. This requirement does not apply to participants who have undergone surgical sterilization. Reliable contraceptive measures include two methods of contraception, including one barrier method
• Patients should be able to follow the Protocol procedures (according to Investigator's assessment)

Exclusion Criteria

• Any other causes of anemia except for renal anemia, including folate and B12 deficiency, chronic blood loss, aluminium intoxication, sickle-cell anemia, chronic disease anemia (CRP above 20 mg/l), refractory anemia with blast cells in peripheral blood
• Lupus nephritis of kidney disease due to systemic vasculitis
• Platelet count below 100х10^9 cells/l
• Hemoglobin above 120 g/l or below 100 g/l
• Scheduled kidney transplant during study participation period
• Binding/neutralizing antibodies against erythropoetin/darbepoetin
• History of severe allergic reactions
• Vaccination less than 8 weeks before enrollment
• Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis
• HIV infection, active HBV, HCV
• ALT, AST level above 3x ULN
• Bone marrow fibrosis
• Congestive heart failure (Grade IV NYHA)
• Resistant arterial hypertension
• Unstable angina
• Hemoglobinopathy, MDS, hematologic malignancy
• PRCA
• Severe secondary hyperparathyroidism (PTH > 9x ULN)
• GI bleeding history
• Thrombotic events history (myocardial infarction, stroke, TIA, DVT, PATE) less than 6 months before enrollment
• Acute hemolysis history
• Seizures, including epilepsy
• Major surgery in less than 1 month before enrollment
• Blood transfusions in less than 3 months before enrollment
• Acute inflammatory diseases or exacerbations of chronic inflammation including septic of aseptic inflammation foci
• Severe psychiatric disorders
• History of malignancy, excluding appropriately treated basal cell carcinoma or cervical carcinoma in situ
• Alcohol or drug abuse
• Hypersensitivity to darbepoetin alfa of any components of study drugs
• Simultaneous participation in other trials or in less than 3 months before enrollment
• Pregnancy of breast-feeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Biryulin, MD

Role: STUDY_DIRECTOR

Biocad

Locations

St. Josaphat Belgorod Regional Clinical Hospital

Belgorod, , Russia

Alyans Biomedical - Ural'skaya gruppa

Izhevsk, , Russia

Kaluga Region Hospital

Kaluga, , Russia

Kazan State Medical University

Kazan', , Russia

Fresenius Medical Care Kuban

Krasnodar, , Russia

NEFROS Ltd, Medical Centre

Krasnodar, , Russia

Centr Dializa Ltd

Moscow, , Russia

City Clinical Hospital #24

Moscow, , Russia

Federal State Budgetary Institution "Academician V.I.Shumakov Federal Research Center of Transplantology and Artificial Organs", Ministry of Health of the Russian Federation

Moscow, , Russia

N.I.Pirogov City Clinical Hospital #1

Moscow, , Russia

Scientific Clinical Centre, JSC Russian Railways

Moscow, , Russia

Nefrolayn-Novosibirsk Ltd

Novosibirsk, , Russia

Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation, Urology and Interventional Radiology Research Institute

Obninsk, , Russia

A.N. Kabanov City Clinical Hospital #1

Omsk, , Russia

Omsk Regional Clinical Hospital

Omsk, , Russia

V.A. Baranov Republican Hospital of Ministry of Health republic Karelia

Petrozavodsk, , Russia

City Mariin Hospital

Saint Petersburg, , Russia

B.Braun Avitum Russland Clinics Ltd.

Saint Petersburg, , Russia

Centr Dializa Sankt-Peterburg Ltd

Saint Petersburg, , Russia

City Hospital #15

Saint Petersburg, , Russia

City Hospital #40, Kurortny district

Saint Petersburg, , Russia

Nikolaevskaya Hospital

Saint Petersburg, , Russia

North-Western State Medical University named after I.I Mechnikov under the Ministry of Public Health of the Russian Federation

Saint Petersburg, , Russia

St.Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine

Saint Petersburg, , Russia

State Healthcare Institution Holy Great Martyr Elizabeth City Hospital #2

Saint Petersburg, , Russia

Regional Clinical Hospital, Saratov

Saratov, , Russia

Smolensk Regional Clinical Hospital

Smolensk, , Russia

Tula Regional Hospital

Tula, , Russia

Fresenius Nephrocare Ltd - Dialysis Centre #2, Ul'yanovsk

Ulyanovsk, , Russia

State Healthcare Institution Volgograd Region Uronephrology Centre

Volgograd, , Russia

Countries

Russia

Other Identifiers

BCD-066-2

Identifier Type: -

Identifier Source: org_study_id