Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To establish the efficacy and Safety of rHu-EPO-alpha in patients with anemia of Chronic Renal Failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cadila Pharnmaceuticals
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients between 18 to 70 yrs of age of either sex.

• CRF patients who are EPO naïve or have been off EPO or similar Erythropoietic drugs for more than 4 weeks, falling with-in CKD stage III to V.

• Patients who are willing to give the consent

• Patient with Anemia of Chronic Renal Failure with Hb < 10.

Exclusion Criteria:

• Patients who are known hypersensitive to rHu-EPO.

• Patient's with history of anemia due to causes other than anemia of CRF.

• Patient's with history of Active infections, Hemoglobinopathies, Neoplastic diseases, and HIV infection.

• Patient's with history of G.I. bleeding (Overt or Occult).

• Patient's with history of serious or unstable medical or psychological conditions that could compromise the patient's safety or successful trial participation.

• Patients with abnormal liver function test. However, patients with HBsAg and HCV positive shall be included provided their Transaminases are normal.

• Female patient's of child bearing potential and not having undergone permanent sterilization procedures. Pregnant and lactating female patients.

• Patients unwilling or unable to comply with the study procedures. Chronic alcoholic or drug abuse patients