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

Information source: Biocad
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Kidney Disease; End Stage Renal Failure on Dialysis; Anemia

Intervention: Darbepoetin alfa (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Biocad

Official(s) and/or principal investigator(s):
Andrey Biryulin, MD, Study Director, Affiliation: Biocad

Overall contact:
Andrey Biryulin, Phone: +7 (812) 380-49-33, Ext: 925, Email: biryulin@biocad.ru

Summary

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

Clinical Details

Official title: Multicenter Double-blind Randomized Parallel Comparative Study of Efficacy and Safety of BCD-066 (CJSC BIOCAD, Russia) and Aranesp (Amgen Europe B.V., Netherlands) in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period

Secondary outcome:

Proportion of Patients Who Have Target Hemoglobin Concentration During Evaluation Period

Mean Darbepoetin Alfa Dose During Evaluation Period

Proportion of Patients with Need for Blood Transfusions

Proportion of Patients with Need for 'Dose Titration' at the Beginning of the Study

Mean Hemoglobin Level During Evaluation Period

Proportion of Patients with Hemoglobin Level Between 90 and 100 g/l

Hemoglobin Level Dynamics

Mean Darbepoetin Alfa Dose During the Whole Study

Mean Hemoglobin Level During the Whole Study

Mean Hematocrit Level During the Whole Study

AE/SAE Incidence

Grade 3-4 AE/SAE Incidence

Premature Study Withdrawal Rate Due to AE/SAE

Incidence of Arterial and Venous Thrombotic Events

Proportion of Patients with Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa

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).

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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 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 10 mg/l), refractory anemia with blast cells in peripheral blood

- Lupus nephritis of kidney disease due to systemic vasculitis

- Platelet count below 100Ñ…10^9 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

Locations and Contacts

Andrey Biryulin, Phone: +7 (812) 380-49-33, Ext: 925, Email: biryulin@biocad.ru

Additional Information

Starting date: September 2015
Last updated: July 22, 2015

Page last updated: August 20, 2015

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