Phase 3
N=196
Safety and Efficacy Study of BCD-066 Compared to Aranesp® for Anemia Treatment in Chronic Kidney Disease Patients
Chronic Kidney Disease · End Stage Renal Failure on Dialysis · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT02506868 ↗Enrolled (actual)
196
Serious AEs
16.4%
Results posted
May 2019
Primary outcome: Primary: Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period — 4.695; 4.641 gram per liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Darbepoetin alfa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biocad
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) Concentration From Baseline to the Evaluation Period |
4.695; 4.641 | — |
| SECONDARY Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period |
61; 61 | — |
| SECONDARY Mean Darbepoetin Alfa Dose During Evaluation Period |
20.779; 20.982 | — |
| SECONDARY Number or Percentage of Patients With Need for Blood Transfusions |
0; 0 | — |
| SECONDARY Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study |
31; 24 | — |
| SECONDARY Mean Hemoglobin Level During Evaluation Period |
114.054; 115.277 | — |
| SECONDARY Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l |
1; 1 | — |
| SECONDARY Hemoglobin Level Dynamics |
111.155; 112.68; 111.831; 113.619; 113.802; 115.378 | — |
| SECONDARY Mean Darbepoetin Alfa Dose During the Whole Study |
22.625; 22.449 | — |
| SECONDARY Mean Hemoglobin Level During the Whole Study (24 Week) |
114.394; 115.434 | — |
| SECONDARY Mean Hematocrit Level During the Whole Study |
35.119; 35.173 | — |
| SECONDARY Number of Patients With AE/SAE (AE/SAE Incidence) |
79; 76 | — |
| SECONDARY Number of Participants With Grade 3-4 AE/SAE |
60; 51 | — |
| SECONDARY Number of Participants Who Withdrew From Study Due to AE/SAE |
6; 4 | — |
| SECONDARY Number of Participants With Arterial and Venous Thrombotic Events |
4; 5 | — |
| SECONDARY Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa |
0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02506868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.