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

June 10, 2009 updated by: Cadila Pharnmaceuticals

Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Gujarat
      • Nadiad, Gujarat, India
        • Dr. Shishir Gang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
OR
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.
Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.

Secondary Outcome Measures

Outcome Measure
Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cadila Pharnmaceuticals

Investigators

  • Principal Investigator: Dr. H. L. Trivedi, MD, IKDRC, Civil Hospital, Ahmedabad
  • Principal Investigator: Dr. Pankaj Shah, Nephrologist, IKDRC, Civil Hospital, Ahmedabad
  • Principal Investigator: Dr. Shishir Gang, Nephrologist, Muljibhai Patel Urological Hospital
  • Principal Investigator: Dr. Himanshu Patel, Nephrologist, Gujarat Kidney Foundation, Ahmedabad
  • Principal Investigator: Dr. Miten Mehta, Nephrologist, Anandabawa Kidney Dialysis Center, Jamnagar
  • Principal Investigator: Dr. Asit Mehta, Nephrologist, Apollo Hospitals, Ahmedabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

November 12, 2006

First Submitted That Met QC Criteria

November 13, 2006

First Posted (ESTIMATE)

November 14, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2009

Last Update Submitted That Met QC Criteria

June 10, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR - 50/9180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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