Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261820
• Other study ID #: 0468E1-100194
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2005
• Last updated: May 17, 2006
• Est. completion date: January 2005

Study information

• Verified date: May 2006
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Rejection
• Kidney Failure
• Kidney Transplantation
• Renal Insufficiency

Intervention

Drug:
• tacrolimus

• mycophenolate mofetil

• methylprednisolone

• prednisolone

• sirolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
Primary	transplantation.
Secondary	Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
Secondary	criteria at 3, 6 and 12 Months following transplantation
Secondary	One year graft biopsy status
Secondary	Incidence of document infection