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

Primary Purpose

Anemia

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Recombinant Human Erythropoietin alpha

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dr. Shishir Gang

Outcomes

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.

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.

Full Information

NCT ID

NCT00399269

First Posted

November 12, 2006

Last Updated

June 10, 2009

Sponsor

Cadila Pharnmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00399269

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cadila Pharnmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia

Keywords

Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Recombinant Human Erythropoietin alpha

Primary Outcome Measure Information:

Title

Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL

Title

and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: