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

NCT02506868 | Completed Phase 3 Results

• 1 other identifier: BCD-066-2
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 30

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.

Conditions

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

Keywords

darbepoetin alfa

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period

  Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 24

Secondary Outcomes (15)

• Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period

  Weeks 21 to 24

• Mean Darbepoetin Alfa Dose During Evaluation Period

  Week 21 to Week 24

• Number or Percentage of Patients With Need for Blood Transfusions

  Weeks 1 to 24

• Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study

  Weeks 1 to 20

• Mean Hemoglobin Level During Evaluation Period

  Week 24

Study Arms (2)

BCD-066

EXPERIMENTAL

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

Drug: Darbepoetin alfa

Aranesp

ACTIVE COMPARATOR

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

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

Weekly sc administration of darbepoetin alfa

Also known as: Aranesp, BCD-066

Aranesp; BCD-066

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocad: lead

Study Sites (30)

St. Josaphat Belgorod Regional Clinical Hospital

Belgorod, Russia

Location

Alyans Biomedical - Ural'skaya gruppa

Izhevsk, Russia

Location

Kaluga Region Hospital

Kaluga, Russia

Location

Kazan State Medical University

Kazan', Russia

Location

Fresenius Medical Care Kuban

Krasnodar, Russia

Location

NEFROS Ltd, Medical Centre

Krasnodar, Russia

Location

Centr Dializa Ltd

Moscow, Russia

Location

City Clinical Hospital #24

Moscow, Russia

Location

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

Location

N.I.Pirogov City Clinical Hospital #1

Moscow, Russia

Location

Scientific Clinical Centre, JSC Russian Railways

Moscow, Russia

Location

Nefrolayn-Novosibirsk Ltd

Novosibirsk, Russia

Location

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

Obninsk, 249036, Russia

Location

A.N. Kabanov City Clinical Hospital #1

Omsk, Russia

Location

Omsk Regional Clinical Hospital

Omsk, Russia

Location

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

Petrozavodsk, 185000, Russia

Location

City Mariin Hospital

Saint Petersburg, 194104, Russia

Location

B.Braun Avitum Russland Clinics Ltd.

Saint Petersburg, Russia

Location

Centr Dializa Sankt-Peterburg Ltd

Saint Petersburg, Russia

Location

City Hospital #15

Saint Petersburg, Russia

Location

City Hospital #40, Kurortny district

Saint Petersburg, Russia

Location

Nikolaevskaya Hospital

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

State Healthcare Institution Holy Great Martyr Elizabeth City Hospital #2

Saint Petersburg, Russia

Location

Regional Clinical Hospital, Saratov

Saratov, Russia

Location

Smolensk Regional Clinical Hospital

Smolensk, Russia

Location

Tula Regional Hospital

Tula, 300053, Russia

Location

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

Ulyanovsk, Russia

Location

State Healthcare Institution Volgograd Region Uronephrology Centre

Volgograd, Russia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

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; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Yulia Linkova Medical Director
• Organization: Biocad

linkova@biocad.ru

+7 (495) 992 66 28

Study Officials

• Andrey Biryulin, MD

  Biocad

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: August 8, 2015
• Primary Completion: January 8, 2017
• Study Completion: December 21, 2017
• Last Updated: May 7, 2020
• Results First Posted: May 30, 2019

Record last verified: 2020-04

Locations

RU (30)