Comparative study of efficacy and safety of Relipoietin and of medicinal drug Eprex® in the treatment of anemia in patients with chronic kidney disease on hemodialysis

Phase 3

Completed

• Conditions: Anemic Patients with Chronic Kidney disease on Hemodialysis

• Registration Number: CTRI/2013/01/003325
• Lead Sponsor: LOK BETA PHARMACEUTICALS I PVT LTD

Brief Summary

Today effective and safe treatment of anemia in patients with chronicrenal failure and requiring dialysis is a serious social and medical problem.

Direct damageto the renal parenchyma, leading to the violation of the endogenouserythropoietin production conditions the fact of anemia of varying severity inall patients with chronic kidney disease. Thus, almost in 90% of patients withchronic renal failure hemoglobin is less than 100 g/L. According to modernRussian and European guidelines treatment of anemia with chronic kidney diseaseand hemoglobin index less than 110 g/L requires the administration oferythropoiesis-stimulating agents.

A new stage in the treatment of symptomatic anemia was the use of drugs,similar in structure and action to endogenous erythropoietin - Recombinant Erythropoietin(Epoetin). Until that time, the only way to treat anemia resulting from chronickidney disease were blood transfusions, the performance of which is associatedwith a known risk.

ReliPoietin - Recombinant Epoetin Alfa. In the conductedclinical studies of early phases it showed its similarity to the original drug EpoetinAlfa, Eprex in terms of pharmacokinetic and pharmacodynamic properties. Thisstudy is designed to demonstrate therapeutic equivalence to the original drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-02
• Last Update Posted: 2015-09-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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 <110 g/L 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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary-Average dose of the test product (IU/kg) for the last 4 weeks of treatment;	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
Average Hemoglobin index for the last 4 weeks of treatment.	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 Outcome Measures

Name	Time	Method
Relative quantity of patients (%), Hemoglobin index of which was within 110±10 g/L for, at least, last two weeks of observation;	•Hemoglobin dynamics for the whole period of patient’s participation in the trial;

Trial Locations

Locations (2)

Aster-Aadhar Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Bhiwandi Dialysis Centre; 🇮🇳 Thane, MAHARASHTRA, India

Aster-Aadhar Hospital

🇮🇳Kolhapur, MAHARASHTRA, India

Dr Abhijit K Korane

Principal investigator

9921792969

metamorphcrpl@gmail.com