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Completed

NCT Number: NCT00261820

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

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.

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Key information

Conditions

Graft Rejection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure Kidney Transplantation Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

Mycophenolate mofetil

Drug

methylprednisolone

Drug

Prednisolone

Drug

sirolimus

Drug

Primary outcomes

  1. - Graft function as measured by Glomerular Filtration Rate (GFR) by Nankivell formula at Month 12 post-

  2. transplantation.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study completion
2005
First posted
Dec 5, 2005
Registry last updated
May 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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