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

Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399269
• Other study ID #: CR - 50/9180
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2006
• Last updated: June 10, 2009
• Start date: December 2006
• Est. completion date: June 2007

Study information

• Verified date: June 2009
• Source: Cadila Pharnmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Recombinant Human Erythropoietin alpha

Locations

Country	Name	City	State
India	Dr. Shishir Gang	Nadiad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Cadila Pharnmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rise in Hemoglobin (Hb)/ Hematocrit (Hct) to therapeutic levels of 10 to 12 g/ dL
Primary	and/ or 30 to 36% respectively suggestive of normalized erythropoiesis at the end of study period of 12 Weeks.
Primary	OR
Primary	Rise in Hb by 1 g/ dL over two weeks of treatment with rHu-EPO.
Secondary	Rise of Hemoglobin and Haematocrit in CRF patients without significant adverse events.