Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
Primary Purpose
Kidney Failure, Graft Rejection, Aged
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sirolimus
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring kidney transplant, elderly
Eligibility Criteria
Inclusion Criteria: End stage renal disease Kidney transplantation Both donor and recipient older than 60 years Exclusion Criteria: Prior or concurrent transplant of any organ other than the kidney Current clinically significant infections
Sites / Locations
Outcomes
Primary Outcome Measures
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
Secondary Outcome Measures
Incidence of acute rejections at 3 and 12 months
Patient and graft survival at 3 and 12 months
Incidence and duration of episodes of acute tubular necrosis
Time to recover renal function (creatinine< 2 mg/dl)
Full Information
NCT ID
NCT00254709
First Posted
November 11, 2005
Last Updated
January 26, 2012
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00254709
Brief Title
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
Official Title
Open, Pilot, Comparative Study to Evaluate the Efficacy and Safety of Two Immunosuppressor Regimens, Anti Il-2, Sirolimus Mycophenolate, Mophetyl and Steroids Versus Sirolimus, Cyclosporine, and Withdrawal of Cyclosporine Since the Third Month and Steroids in Elderly Population
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Graft Rejection, Aged
Keywords
kidney transplant, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Primary Outcome Measure Information:
Title
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine
Secondary Outcome Measure Information:
Title
Incidence of acute rejections at 3 and 12 months
Title
Patient and graft survival at 3 and 12 months
Title
Incidence and duration of episodes of acute tubular necrosis
Title
Time to recover renal function (creatinine< 2 mg/dl)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End stage renal disease
Kidney transplantation
Both donor and recipient older than 60 years
Exclusion Criteria:
Prior or concurrent transplant of any organ other than the kidney
Current clinically significant infections
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
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
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