Health Condition 1: null- Anemic Patients with Chronic Kidney disease on Hemodialysis
Conditions
Interventions
Intervention1: ReliPoietin (Reliance Life Sciences Pvt. Ltd., India): Trade name: ReliPoietin
International Nonproprietary Name: Epoetin Alfa
Dosage form: solution for intravenous and subcutaneo
Sponsors
LOK BETA PHARMACEUTICALS I PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: 1)Written informed consent. 2)End stage of chronic kidney disease. 3)The need for hemodialysis for at least the last 3 months before inclusion in the study. 4)The need for standard hemodialysis with total duration of at least 12 hours per week. 5)The established efficacy of hemodialysis. Hemoglobin 6)Transferrin saturation >20%, Ferritin level >100 ng/ml 7) Ability of patient, according to the Investigator, to comply with the protocol procedures 8)Readiness of patients with preserved reproductive function to use reliable methods of contraception
Exclusion criteria
Exclusion criteria: 1)The use of any erythropoiesis-stimulating agents (other erythropoietins, androgens) within 8 weeks prior to study entry. 2)Blood transfusion within four weeks prior to study entry. 3)Any other genesis of anemia, with the exception of renal (folic acid and B12-deficiency anemia, and other types of anemia) 4)Anemia of chronic disease (activity of C-reactive protein > 10 mg / l) 5)Refractory anemia in the presence of blast transformed cells in peripheral blood 6)Diagnosed lupus nephritis or chronic kidney disease in patient developed as a consequence of systemic angiitis; 7)Presence of neutralizing antibodies to erythropoietin. 8)Vaccination within 8 weeks before study entry 9)Hepatic cirrhosis complicated with portal hypertension, and/or splenomegaly, and/or ascites 9)HIV-infection, advanced Hepatitis Ð?, С 10)Activity of ALAT, AST > 3ULN 11)Epilepsy (including in past medical history) 12)Obliterative peripheral vascular disease 13)Porphyria 14)Confirmed bone marrow fibrosis 15)Acute decompensated heart failure 16)Uncontrolled hypertension 17)Unstable angina 18)Diagnosed severe secondary hyperparathyroidism 19)Episodes of gastrointestinal bleeding in history 20)Episodes of thrombosis in history (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary embolism) within six months prior to study entry, as well as an increased risk of deep vein thrombosis 21)History of acute hemolytic episodes 22)Abdominal operation within 1 month prior to study entry 23)Any acute inflammatory disease or exacerbation of chronic diseases, including identified foci of septic and aseptic inflammation 24)Malignancy, except cured basal cell carcinoma and cervical cancer in situ; any malignancy with a duration of complete remission for more than 5 years 25)Drug addiction, alcohol abuse 26)Hypersensitivity to Epoietin alpha or to any components of study drugs 27)Pregnancy or lactation 28)Simultaneous participation in other clinical trials, and prior participation in other clinical trials within 3 months before inclusion in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary-Average dose of the test product (IU/kg) for the last 4 weeks of treatment; Average Hemoglobin index for the last 4 weeks of treatment. Average Hemoglobin index for the last 4 weeks of treatment. Timepoint: administered intravenously (over 1-5minutes) on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, 54, 57, 59, 61, 64, 66, 68, 71, 73, 75, 78, 80, 82, 85, 87, 89, 92, 94, 96, 99, 101, 103, 106, 108, 110, 113, 115, 117, 120, 122, 124, 127, 129, 131, 134, 136, 138, 141, 143, 145, 148, 150, 152, 155, 157, 159, 162, 164, 166 | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative quantity of patients (%), Hemoglobin index of which was within 110±10 g/L for, at least, last two weeks of observation; â?¢Hemoglobin dynamics for the whole period of patientâ??s participation in the trial; â?¢Average index of hemoglobin for each four-week period of treatment; â?¢Average hematocrit index for each four-week period of treatment; â?¢Relative quantity of patients with hemoglobin increment 10-20 g/L for each four-week period. Timepoint: administered intravenously (over 1-5minutes) on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, 54, 57, 59, 61, 64, 66, 68, 71, 73, 75, 78, 80, 82, 85, 87, 89, 92, 94, 96, 99, 101, 103, 106, 108, 110, 113, 115, 117, 120, 122, 124, 127, 129, 131, 134, 136, 138, 141, 143, 145, 148, 150, 152, 155, 157, 159, 162, 164, 166 | — |
Countries
India, Russian Federation
Contacts
Public ContactDr Amit Bhatt
NEXUS CLINICAL RESEARCH (INDIA) LTD.
Outcome results
None listed