Back to resultsStudy Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Primary Purpose
Graft Rejection, Kidney Failure, Kidney Transplantation
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tacrolimus
mycophenolate mofetil
methylprednisolone
prednisolone
sirolimus
Sponsored by
About this trial
This is an interventional treatment trial for Graft Rejection focused on measuring Kidney Transplant
Eligibility Criteria
Inclusion Criteria: Age: 18 and < 65 years End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant Exclusion Criteria: Evidence of active systemic or localized major infection at the time of initial sirolimus administration Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
Sites / Locations
Outcomes
Primary Outcome Measures
- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
transplantation.
Secondary Outcome Measures
Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
criteria at 3, 6 and 12 Months following transplantation
One year graft biopsy status
Incidence of document infection
Full Information
NCT ID
NCT00261820
First Posted
December 2, 2005
Last Updated
May 17, 2006
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00261820
Brief Title
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Official Title
A Randomized Study To Compare The Safety And Efficacy Of Two Immunosuppressive Regimens In De Novo Renal Allograft Recipients:Sirolimus Plus Mycophenolate Mofetil Plus Corticosteroids Following A Rabbit Anti-Human Thymocyte Globulin Induction (RATG) Vs Tacrolimus Plus Mycophenolate Mofetil Plus Corticosteroids
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil following an antibody induction (RATG) or a standard regimen combining tacrolimus plus mycophenolate mofetil, both regimens including corticosteroids in patients undergoing renal allograft transplantation. In addition, the two treatment groups will be compared with respect to the incidence of acute rejection at 3, 6 and 12 months following transplantation, and the patient and graft survival at 6 and 12 months after transplantation. The safety of sirolimus plus mycophenolate mofetil following an antibody induction (ATG) will be evaluated beginning in the immediate post-operative period.
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 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Intervention Type
Drug
Intervention Name(s)
mycophenolate mofetil
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
sirolimus
Primary Outcome Measure Information:
Title
- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
Title
transplantation.
Secondary Outcome Measure Information:
Title
Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
Title
criteria at 3, 6 and 12 Months following transplantation
Title
One year graft biopsy status
Title
Incidence of document infection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18 and < 65 years
End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant
Exclusion Criteria:
Evidence of active systemic or localized major infection at the time of initial sirolimus administration
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
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 Belgium, trials-BEL@wyeth.com
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trial Manager
Organizational Affiliation
For France, infomedfrance@wyeth.com
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
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