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Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

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ClinicalTrials.gov Identifier: NCT00261820
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : May 19, 2006
Information provided by:

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Estimated Study Completion Date : January 2005
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. - Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-
  2. transplantation.

Secondary Outcome Measures :
  1. Incidence of occurrence of primary acute rejection biopsy confirmed by a local pathologist using the 1997 Banff
  2. criteria at 3, 6 and 12 Months following transplantation
  3. One year graft biopsy status
  4. Incidence of document infection

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
More Information

ClinicalTrials.gov Identifier: NCT00261820     History of Changes
Other Study ID Numbers: 0468E1-100194
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: May 19, 2006
Last Verified: May 2006

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Mycophenolic Acid
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Inflammatory Agents