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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00399269
Recruitment Status : Completed
First Posted : November 14, 2006
Last Update Posted : June 11, 2009
Information provided by:
Cadila Pharnmaceuticals

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

Condition or disease Intervention/treatment Phase
Anemia Drug: Recombinant Human Erythropoietin alpha Phase 3

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00399269

Dr. Shishir Gang
Nadiad, Gujarat, India
Sponsors and Collaborators
Cadila Pharnmaceuticals
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 Identifier: NCT00399269     History of Changes
Other Study ID Numbers: CR - 50/9180
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by Cadila Pharnmaceuticals:

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Hematologic Diseases
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Epoetin Alfa