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

NCT00399269 | Completed Phase 3

• 1 other identifier: CR - 50/9180
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anemia

Keywords

Anemia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

Interventions

Recombinant Human Erythropoietin alpha DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead

Study Sites (1)

Dr. Shishir Gang

Nadiād, Gujarat, India

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 12, 2006
• First Posted: November 14, 2006
• Study Start: December 1, 2006
• Study Completion: June 1, 2007
• Last Updated: June 11, 2009

Record last verified: 2009-06

Locations

IN (1)