Status:
COMPLETED
Efficacy & Safety Study of Recombinant Human Erythropoietin -Alpha, in Patients With Anemia of Chronic Renal Failure
Lead Sponsor:
Cadila Pharnmaceuticals
Conditions:
Anemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00399269
Start Date
December 1 2006
End Date
June 1 2007
Last Update
June 11 2009
Active Locations (1)
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1
Dr. Shishir Gang
Nadiād, Gujarat, India