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

Phase 3

Completed

• Conditions: Anemia

• Registration Number: NCT00399269
• Lead Sponsor: Cadila Pharnmaceuticals

Brief Summary

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

Detailed Description

Despite impressive advances in the safety of the blood supply, the search for therapeutic alternatives to blood continues. Recombinant Human Erythropoietin (rHu-EPO), along with iron, vitamin B12, and folic acid, has been recommended as a specific medication that should be used instead of blood transfusion if the clinical condition of the patient permits sufficient time for these agents to promote erythropoiesis.

In normal physiological conditions Erythropoietin is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. rHu-EPO is a glycoprotein which stimulates red blood cell production. Epoetin alfa, a 165 amino acid glycoprotein manufactured by recombinant DNA technology, has the same biological effects as endogenous rHu-EPO.

Study Timeline

• Study First Submitted: 2006-11-12
• Study First Submitted QC: 2006-11-13
• Study First Posted: 2006-11-14
• Study Start: 2006-12
• Study Completion: 2007-06
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
OR
Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.

Secondary Outcome Measures

Name	Time	Method
Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.

Trial Locations

Locations (1)

Dr. Shishir Gang; 🇮🇳 Nadiad, Gujarat, India