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Clinical Trial Details

Trial ID: L1459
Source ID: NCT02506868
Associated Drug: Darbepoetin Alfa
Title: Safety and Efficacy Study of BCD-066 Compared to AranespĀ® for Anemia Treatment in Chronic Kidney Disease Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02506868/results
Conditions: Chronic Kidney Disease|End Stage Renal Failure on Dialysis|Anemia
Interventions: DRUG: Darbepoetin alfa
Outcome Measures: Primary: 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: Number or Percentage of Patients Who Have Target Hemoglobin Concentration During Evaluation Period, Hb concentration between 100 and 120 g/l will be considered as target, Weeks 21 to 24|Mean Darbepoetin Alfa Dose During Evaluation Period, The outcome includes the mean weekly dose of Darbepoetin Alfa which was administered to the patients during the period from week 21 to week 24 (last 4 weeks of the main period of the study), 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, The outcome includes the mean hemoglobin level which was registered in the patients during the last 4 weeks of the main period of the study (period from week 21 to week 24), Week 24|Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l, Weeks 21 to 24|Hemoglobin Level Dynamics, Weeks 1 to 24|Mean Darbepoetin Alfa Dose During the Whole Study, The outcome includes the mean Darbepoetin Alfa Dose During the Whole Study, Week 24|Mean Hemoglobin Level During the Whole Study (24 Week), The outcome includes the measuere of Mean Hemoglobin Level During the Whole Study (during the study period from week 1 to week 24 week), Week 24|Mean Hematocrit Level During the Whole Study, Week 24|Number of Patients With AE/SAE (AE/SAE Incidence), Weeks 1 to 52|Number of Participants With Grade 3-4 AE/SAE, Weeks 1 to 52|Number of Participants Who Withdrew From Study Due to AE/SAE, Weeks 1 to 52|Number of Participants With Arterial and Venous Thrombotic Events, Weeks 1 to 52|Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa, Weeks 1 to 52
Sponsor/Collaborators: Sponsor: Biocad
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 196
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-08-08
Completion Date: 2017-12-21
Results First Posted: 2019-05-30
Last Update Posted: 2020-05-07
Locations: St. Josaphat Belgorod Regional Clinical Hospital, Belgorod, Russian Federation|Alyans Biomedical - Ural'skaya gruppa, Izhevsk, Russian Federation|Kaluga Region Hospital, Kaluga, Russian Federation|Kazan State Medical University, Kazan, Russian Federation|Fresenius Medical Care Kuban, Krasnodar, Russian Federation|NEFROS Ltd, Medical Centre, Krasnodar, Russian Federation|Centr Dializa Ltd, Moscow, Russian Federation|City Clinical Hospital #24, Moscow, Russian Federation|Federal State Budgetary Institution "Academician V.I.Shumakov Federal Research Center of Transplantology and Artificial Organs", Ministry of Health of the Russian Federation, Moscow, Russian Federation|N.I.Pirogov City Clinical Hospital #1, Moscow, Russian Federation|Scientific Clinical Centre, JSC Russian Railways, Moscow, Russian Federation|Nefrolayn-Novosibirsk Ltd, Novosibirsk, Russian Federation|Medical Radiological Research Center, Ministry of Health and Social Development of the Russian Federation, Urology and Interventional Radiology Research Institute, Obninsk, 249036, Russian Federation|A.N. Kabanov City Clinical Hospital #1, Omsk, Russian Federation|Omsk Regional Clinical Hospital, Omsk, Russian Federation|V.A. Baranov Republican Hospital of Ministry of Health republic Karelia, Petrozavodsk, 185000, Russian Federation|Regional Clinical Hospital, Saratov, Saratov, Russian Federation|Smolensk Regional Clinical Hospital, Smolensk, Russian Federation|City Mariin Hospital, St. Petersburg, 194104, Russian Federation|City Hospital #40, Kurortny district, St. Petersburg, Russian Federation|Nikolaevskaya Hospital, St. Petersburg, Russian Federation|B.Braun Avitum Russland Clinics Ltd., St.Petersburg, Russian Federation|Centr Dializa Sankt-Peterburg Ltd, St.Petersburg, Russian Federation|City Hospital #15, St.Petersburg, Russian Federation|North-Western State Medical University named after I.I Mechnikov under the Ministry of Public Health of the Russian Federation, St.Petersburg, Russian Federation|St.Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine, St.Petersburg, Russian Federation|State Healthcare Institution Holy Great Martyr Elizabeth City Hospital #2, St.Petersburg, Russian Federation|Tula Regional Hospital, Tula, 300053, Russian Federation|Fresenius Nephrocare Ltd - Dialysis Centre #2, Ul'yanovsk, Ul'yanovsk, Russian Federation|State Healthcare Institution Volgograd Region Uronephrology Centre, Volgograd, Russian Federation
URL: https://clinicaltrials.gov/show/NCT02506868