Back to resultsA Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Primary Purpose
Kidney Failure, Graft vs Host Disease
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Tacrolimus
Sirolimus
prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring Kidney, Transplant
Eligibility Criteria
Inclusion Criteria: End-stage renal disease, with patients scheduled to receive a kidney transplant. Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs; Signed informed consent. Exclusion Criteria: Evidence of active systemic or localized major infection at the time of initial study drug administration; Multiple organ transplants; Any pathology or medical condition that can interfere with this protocol study proposal. Other exclusion applies.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sirolimus + Tacrolimus
Sirolimus + Prednisone
Arm Description
Outcomes
Primary Outcome Measures
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).
Secondary Outcome Measures
Creatinine Clearance Rate
Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Full Information
NCT ID
NCT00195429
First Posted
September 12, 2005
Last Updated
April 22, 2010
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195429
Brief Title
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Official Title
A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sirolimus + Tacrolimus
Arm Type
Experimental
Arm Title
Sirolimus + Prednisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Intervention Type
Drug
Intervention Name(s)
prednisone
Primary Outcome Measure Information:
Title
Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
Description
Diagnosis of acute rejection was made via kidney biopsy using the Banff criteria (a standardized model for interpretation of renal allograft biopsies).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Creatinine Clearance Rate
Description
Creatinine clearance is a measure of kidney function. Creatinine clearance rate (CCr) is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Creatinine clearance can be measured directly or estimated using established formulas. For this study, CCr was calculated using the Nakivell formula. Normal values for healthy, young males are in the range of 100-135 ml/min and for females, 90-125 ml/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
End-stage renal disease, with patients scheduled to receive a kidney transplant.
Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
Signed informed consent.
Exclusion Criteria:
Evidence of active systemic or localized major infection at the time of initial study drug administration;
Multiple organ transplants;
Any pathology or medical condition that can interfere with this protocol study proposal.
Other exclusion applies.
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 Brazil, xavierl@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
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