Back to resultsStudy Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
Primary Purpose
Graft Rejection, Kidney Failure, Kidney Transplantation
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Cyclosporin or tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Graft Rejection focused on measuring kidney transplant
Eligibility Criteria
Inclusion Criteria: Age over 18 Treatment with a calcineurin inhibitor Patients with mild to moderate renal insufficiency Exclusion Criteria: Patients with acute rejection Patients who received a transplant more than 10 years ago
Sites / Locations
Outcomes
Primary Outcome Measures
Difference between treatment groups in renal function at 12 months.
Secondary Outcome Measures
Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.
Full Information
NCT ID
NCT00273871
First Posted
January 5, 2006
Last Updated
March 7, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00273871
Brief Title
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
Official Title
A Multi-centre, Randomized, Open-label, Study to Compare Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients on Maintenance Therapy With Mild to Moderate Renal Insufficiency.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Rejection, Kidney Failure, Kidney Transplantation
Keywords
kidney transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
190 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cyclosporin or tacrolimus
Primary Outcome Measure Information:
Title
Difference between treatment groups in renal function at 12 months.
Secondary Outcome Measure Information:
Title
Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18
Treatment with a calcineurin inhibitor
Patients with mild to moderate renal insufficiency
Exclusion Criteria:
Patients with acute rejection
Patients who received a transplant more than 10 years ago
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
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For United Kingdom and Ireland, ukmedinfo@wyeth.com
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients
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