A clinical trial to evaluate efficacy and safety of Relipoietin in patients with anemia due to Kidney disease
Phase 3
Completed
- Conditions
- Patients with Chronic Kidney Disease
- Registration Number
- CTRI/2010/091/000064
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- Brief Summary
This is a Prospective, Multicentric, Open-label, Study to determine the Safety and Efficacy of ReliPoietinTM when given intravenously to Patients of CKD (Chronic Kidney Disease) with Anemia. 75 subjects will be enrolled across multicenters in India. 10,000 IU of ReliPoietinTM will be administered once weekly for 8 weeks. Primary outcome will be the mean rise in Hb from baseline to EOS. Secondary outcome will be the safety of ReliPoietin during study period. Patients will be followed up to week 9.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
- Patients with Hb levels between 7 & 10g/dL (both inclusive).
- Patients with chronic kidney disease 3.
- Patients with a therapeutic indication for treatment of anemia, after correction of anemia secondary to iron, folate or B12 deficiency (Transferrin saturation > 20%, Serum Ferritin > 100ng/ml) 4.
- Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures/documented to be postmenopausal 5.
- Able to comprehend and willing to give informed consent for the study and willing to come for follow up visit as per protocol requirement.
- If the subject is illiterate, then the consent will be taken in the presence of impartial witness.
Exclusion Criteria
- Patients with uncontrolled hypertension ≥180/100 at screening 2.
- Patients with h/o blood clotting abnormalities 3.
- Patients with micro or macrocytosis (mean corpuscular volume 72 or 110 μm3) 4.
- Treatment for any infection with drugs known to affect erythropoiesis, including androgens and angiotensin-converting enzyme (ACE) inhibitors.
- Patients with known history of allergy to mammalian cell derived products 6.
- Patients with known history of allergy to human serum albumin 7.
- Patients who are known hypersensitive to rHu-EPO 9.
- Patients with history of anemia due to causes other than anemia of CKD, abnormal parathyroid hormone levels 10.
- Patients with history of Active infections, Hemoglobinopathies, Neoplastic diseases 11.
- Patients with HIV infection 12.
- Patients with Known history of G.I. bleeding 13.
- Patients with history of serious or unstable medical or psychological conditions that could compromise the patients safety or successful trial participation 14.
- Patients with abnormal liver function tests (SGOT2.5 X ULN, SGPT 2.5 X ULN, Bilirubin 2.5 X ULN, Alkaline Phosphatase 2.5 X ULN).
- However, patients with HBsAg and HCV positive can be included provided their transaminases are normal 15.
- Pregnant and lactating female patients 16.
- Patients unwilling or unable to comply with the study procedures.
- History of Chronic alcoholic or drug abuse patients 18.
- Patients with other systemic disorders who are not suitable for enrolling into the study on the discretion of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To achieve the rise in Hb in patients of Chronic Kidney Disease with anemia 8 weeks
- Secondary Outcome Measures
Name Time Method 1. To achieve improvement in hematocrit values 2. To study the safety of ReliPoietin
Trial Locations
- Locations (3)
Gujarat Kidney Foundation
🇮🇳Ahmadabad, GUJARAT, India
Sanjeevani Kidney Care
🇮🇳Mumbai, MAHARASHTRA, India
Tanker Foundation
🇮🇳Chennai, TAMIL NADU, India
Gujarat Kidney Foundation🇮🇳Ahmadabad, GUJARAT, IndiaDr Jagdeep ShahPrincipal investigator9825071369drjagdeepshah@yahoo.com