Study Evaluating Sirolimus in Kidney Transplant Recipients in India

Phase 4

Completed

• Conditions: Kidney Failure; Graft vs Host Disease

• Registration Number: NCT00195481
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-21
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
• Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

Exclusion Criteria

• Evidence of major infections at the time of sirolimus administration
• Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
• Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety evaluation