Back to resultsStudy Evaluating Sirolimus in Kidney Transplant Recipients in India
Primary Purpose
Kidney Failure, Graft vs Host Disease
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Rapamune
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring Kidney, Transplant
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Safety evaluation
Secondary Outcome Measures
Full Information
NCT ID
NCT00195481
First Posted
September 12, 2005
Last Updated
December 21, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195481
Brief Title
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
Official Title
A Post Marketing Surveillance Looking at Safety of Rapamune (Sirolimus) in Indian Population Undergoing de Novo Renal Transplantation.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Graft vs Host Disease
Keywords
Kidney, Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Rapamune
Primary Outcome Measure Information:
Title
Safety evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
566 006
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
566 018
Country
India
City
Saket
State/Province
South Delhi
Country
India
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 004
Country
India
City
New Delhi
Country
India
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Sirolimus in Kidney Transplant Recipients in India
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