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

This study has been completed.
Sponsor:
Information provided by:
Cadila Pharnmaceuticals
ClinicalTrials.gov Identifier:
NCT00399269
First received: November 12, 2006
Last updated: June 10, 2009
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Anemia
 Drug: Recombinant Human Erythropoietin alpha
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Efficacy & Safety of Recombinant Human Erythropoietin -Alpha, (rHu-EPO-Alpha) in Patients With Anemia of Chronic Renal Failure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cadila Pharnmaceuticals:

Primary Outcome Measures:
  • 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:
  • Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.

Enrollment: 100
Study Start Date: December 2006
Study Completion Date: June 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399269

Locations
India
Dr. Shishir Gang
Nadiad, Gujarat, India
Sponsors and Collaborators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00399269     History of Changes
Other Study ID Numbers: CR - 50/9180
Study First Received: November 12, 2006
Last Updated: June 10, 2009
Health Authority: India: Ministry of Health

Keywords provided by Cadila Pharnmaceuticals:
Anemia

Additional relevant MeSH terms:
Anemia
Kidney Failure, Chronic
Renal Insufficiency
Hematologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
 Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013