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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: December 2, 2005
Last updated: May 17, 2006
Last verified: May 2006

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.

Condition Intervention Phase
Graft Rejection
Kidney Failure
Kidney Transplantation
Drug: tacrolimus
Drug: mycophenolate mofetil
Drug: methylprednisolone
Drug: prednisolone
Drug: sirolimus
Phase 4

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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 160
Estimated Study Completion Date: January 2005

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00261820

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Belgium,
Principal Investigator: Trial Manager For France,
  More Information

No publications provided Identifier: NCT00261820     History of Changes
Other Study ID Numbers: 0468E1-100194
Study First Received: December 2, 2005
Last Updated: May 17, 2006
Health Authority: France: Ministry of Health
Belgium: Institutional Review Board

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney Transplant

Additional relevant MeSH terms:
Immunosuppressive Agents
Mycophenolate mofetil
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 03, 2015