Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in CKD Patients on Dialysis

NCT03519243 | Completed Phase 2 Results

• 1 other identifier: BCD-131-2
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 3

Brief Summary

BCD-131 is pegylated darbepoetin beta. BCD-131-2 is International Multicenter Randomized Open-Label Comparative Study (Phase II) of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

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

  The baseline hemoglobin will be calculated as the arithmetic mean of hemoglobin values obtained at screening and at Visit 1. The final hemoglobin value during the evaluation period will be calculated as the arithmetic mean of hemoglobin values obtained at Week 21 and Week 23.

  Baseline - measurements on Screening (weeks -4 - 0) and on day 1; Evaluation period - weekly measures on weeks 21 to 23

Secondary Outcomes (7)

• The Proportion of Patients Who Developed AEs/SAEs That, in the Investigator's Opinion, Are Related to BCD-131

  Week 23

• The Proportion of BAb- and NAb-positive Patients

  Week 9, 23

• AUC(0-672 Hour)

  3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1

• AUC(0-∞)

  3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21

• Cmax

  3, 6, 12, 24, 48, 72, 96, 168, 336, 504, 672 h h after injection 1, weeks 5, 9, 13, 17, 21

Study Arms (4)

BCD-131 1,05 mcg/kg * conversion ratio

EXPERIMENTAL

subcutaneously monthly

Biological: BCD-131

BCD-131 1,7 mcg/kg * conversion ratio

EXPERIMENTAL

subcutaneously monthly

Biological: BCD-131

BCD-131 2,75 mcg/kg * conversion ratio

EXPERIMENTAL

Subcutaneously monthly

Biological: BCD-131

Mircera

ACTIVE COMPARATOR

subcutaneously monthly

Biological: Mircera

Interventions

BCD-131 BIOLOGICAL

subcutaneously monthly

Also known as: pegylated darbepoetin beta

BCD-131 1,05 mcg/kg * conversion ratio; BCD-131 1,7 mcg/kg * conversion ratio; BCD-131 2,75 mcg/kg * conversion ratio

Mircera BIOLOGICAL

subcutaneously monthly

Also known as: Methoxy polyethylene glycol-epoetin beta

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:

• Signed written informed consent.
• Men and women aged from 18 to 75 years (inclusive) on the day of signing informed consent;
• End-stage kidney disease.
• Need for dialysis for at least 3 months before signing informed consent.
• Need for at least 12 hours on standard dialysis procedure weekly.
• rHuEpo (epoetin alpha, epoetin beta, darbepoetin alpha) administration for at least 3 months before signing informed consent.
• Regular rHuEpo (epoetin alfa, epoetin beta, darbepoetin alfa) administration 1, 2 or 3 times a week (stable dose, stable frequency) before signing informed consent.
• Target hemoglobin level (100-120 g/l) for at least 3 months before signing informed consent.
• Effective dialysis dose index (Kt/v) ≥1.2 for patients receiving hemodialysis and (Kt/v) ≥1.7 for patients receiving peritoneal dialysis.
• 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

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.
• Scheduled kidney transplant during study participation period.
• Hypersensitivity to darbepoetin alfa or of any components of study drugs, or to Fe (III)-hydroxide-sucrose complex.
• Vaccination less than 8 weeks before signing informed consent.
• Liver cirrhosis with portal hypertension and/or splenomegaly and/or ascitis.
• HIV infection, active HBV, HCV.
• ALT, AST level above 3x ULN.
• Congestive heart failure (Grade IV NYHA)
• Resistant arterial hypertension.
• Unstable angina.
• Hemoglobinopathy, MDS, hematologic malignancy, PRCA.
• Severe secondary hyperparathyroidism.
• Gastrointestinal bleeding history.

Sponsors & Collaborators

• Biocad: lead

Study Sites (3)

City Clinical Hospital №9

Minsk, Belarus

Location

City Mariin Hospital

Saint Petersburg, 194104, Russia

Location

B.Braun Avitum Russland Clinics Ltd.

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Linkova Iuliia
• Organization: BIOCAD

linkova@biocad.ru

+7 (495) 992 66 28

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 8, 2018
• Study Start: October 24, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 10, 2018
• Last Updated: March 4, 2021
• Results First Posted: July 26, 2019

Record last verified: 2021-02

Locations

RU (2); BE (1)