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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02506868
Other study ID # BCD-066-2
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 8, 2015
Est. completion date December 21, 2017

Study information

Verified date April 2020
Source Biocad
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date December 21, 2017
Est. primary completion date January 8, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 100?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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Darbepoetin alfa
Weekly sc administration of darbepoetin alfa

Locations

Country Name City State
Russian Federation 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
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
Russian Federation Regional Clinical Hospital, Saratov Saratov
Russian Federation Smolensk Regional Clinical Hospital Smolensk
Russian Federation City Hospital #40, Kurortny district St. Petersburg
Russian Federation City Mariin Hospital 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
Russian Federation Fresenius Nephrocare Ltd - Dialysis Centre #2, Ul'yanovsk Ul'yanovsk
Russian Federation State Healthcare Institution Volgograd Region Uronephrology Centre Volgograd

Sponsors (1)

Lead Sponsor Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
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
Secondary 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
Secondary Number or Percentage of Patients With Need for Blood Transfusions Weeks 1 to 24
Secondary Number or Percentage of Patients With Need for 'Dose Titration' at the Beginning of the Study Weeks 1 to 20
Secondary 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
Secondary Number or Percentage of Patients With Hemoglobin Level Between 90 and 100 g/l Weeks 21 to 24
Secondary Hemoglobin Level Dynamics Weeks 1 to 24
Secondary Mean Darbepoetin Alfa Dose During the Whole Study The outcome includes the mean Darbepoetin Alfa Dose During the Whole Study Week 24
Secondary 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
Secondary Mean Hematocrit Level During the Whole Study Week 24
Secondary Number of Patients With AE/SAE (AE/SAE Incidence) Weeks 1 to 52
Secondary Number of Participants With Grade 3-4 AE/SAE Weeks 1 to 52
Secondary Number of Participants Who Withdrew From Study Due to AE/SAE Weeks 1 to 52
Secondary Number of Participants With Arterial and Venous Thrombotic Events Weeks 1 to 52
Secondary Number or Percentage of Patients With Binding and/or Neutralizing Antibodies Against Darbepoetin Alfa Weeks 1 to 52
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