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 PeriodMean 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
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