A Clinical Study to determine the Safety & Efficacy of Recombinant Human Erythropoietin (rHuEPO) Injection In Treatment of Anemia Associated With Chronic Renal Failure

Phase 3

Recruiting

• Conditions: Anemia associated with Chronic Renal Failure

• Registration Number: CTRI/2012/12/003201
• Lead Sponsor: Trigenesis Life Sciences Pvt Ltd

Brief Summary

This will be a multicentric, open-label, randomised, comparative, non-inferiority phase III clinical trial involving patients with anemia associated with chronic renal failure receiving Recombinant human erythropoietin injection (Investigationa product) or Eprex (comparator product) two times in a week for 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-23
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Male or female patients diagnosed with chronic renal failure, age 18 – 80 years (both inclusive).
• Patient / legally acceptable representative (LAR) of patient willing to sign and date written informed consent to participate in the study.
• However, if the patient/LAR of patient is illiterate, the impartial witness would sign the ICF.
• Patient receiving Haemodialysis two-three times per week for at least 6 weeks with or without Recombinant Human Erythropoietin (rHuEPO) treatment before screening.
• Patients with no planned change in dialysis modality and no planned with renal transplant.
• Patients with at least 9.0 g/dL and less than or equal to 12.0 g/dL of the haemoglobin concentration during the screening period.
• Willingness to comply with the study schedule and procedures.

Exclusion Criteria

• Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
• Patients with history of uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or Systolic blood pressure; more than or equal to 180 mm Hg) despite at least one anti-hypertensive therapy during past three weeks.
• Patients with congestive heart failure (CHF).
• Patients with history of malignancy (including hematologic malignancy) and systemic blood disorder (myelodysplastic syndrome, pure red cell aplasia, hemolytic anaemia).
• Patients with history of blood transfusion in past six weeks.
• Patients with history of major surgery in last 12 weeks or planned surgery in next 12 weeks.
• Patients with immunosuppressive therapy.
• Patient whose SGPT or SGOT level is two times the upper limit of normal laboratory range during screening.
• Patient with history of hypersensitivity to albumin (human), hypersensitivity to mammalian cell derived products.
• Patients with history of smoking (10 cigarettes/day) and/or consumption of alcohol (2 small pegs/day) within last three months.
• Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
• Participation in any other clinical trial during last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in haemoglobin level from baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in hematocrit level from baseline, Unstable haemoglobin level during treatment period	12 weeks

Trial Locations

Locations (4)

Dr Jivraj Mehta Smarak Health Foundation; 🇮🇳 Ahmadabad, GUJARAT, India

Pravar Superspeciality Centre; 🇮🇳 Surat, GUJARAT, India

Sapthagiri Institute of Medical Sciences & Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Shree Krishna Hospital and Medical Research Centre; 🇮🇳 Anand, GUJARAT, India

Dr Jivraj Mehta Smarak Health Foundation

🇮🇳Ahmadabad, GUJARAT, India

Dr Jagdeep Shah

Principal investigator

07926639840

research@jivrajhealthcare.org