Back to resultsStudy Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Primary Purpose
Kidney Failure, Graft vs Host Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
CYCLOSPORINE
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring Kidney Failure, Transplant
Eligibility Criteria
Inclusion Criteria: Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age. Exclusion Criteria: Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
Sites / Locations
Outcomes
Primary Outcome Measures
Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
Secondary Outcome Measures
Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.
Full Information
NCT ID
NCT00195468
First Posted
September 13, 2005
Last Updated
March 7, 2011
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00195468
Brief Title
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Official Title
A Randomized, Open-label Study to Compare the Safety and Efficacy of Cyclosporine Dose Reduction With Cyclosporine Elimination in De Novo Renal Allograft Recipients Receiving Rapamune.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 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
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (CsA) and Rapamune followed by CsA dose reduction (Group I) with subjects receiving induction therapy with CsA and Rapamune followed by CsA discontinuation (Group II).
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 Failure, Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CYCLOSPORINE
Primary Outcome Measure Information:
Title
Calculated creatinine clearance at 12 months post transplantation for patients on therapy.
Secondary Outcome Measure Information:
Title
Calculated creatinine clearance at 6 months Serum creatinine at 6 and 12 months post-transplantation. Graft survival at 6 and 12 months post-transplantation. Incidence of biopsy confirmed acute graft rejections at 6 and 12 months post transplantation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.
Exclusion Criteria:
Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
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
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For Mexico, gomezlj@wyeth.com
Official's Role
Principal Investigator
Facility Information:
City
Curitiba
State/Province
PR
ZIP/Postal Code
80730-150
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21041-030
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-590
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90020-090
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
City
Ribeirao Preto
State/Province
RS
ZIP/Postal Code
14048-900
Country
Brazil
City
Sao Jose do Rio Preto
State/Province
SP
ZIP/Postal Code
15015-200
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-001
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04038-002
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
City
Torreon
State/Province
Coahuila
ZIP/Postal Code
27000
Country
Mexico
City
Chihuahua
Country
Mexico
City
Mexico City DF
ZIP/Postal Code
14000
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
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