Comparison of Sirolimus to Tacrolimus for Long Term Therapy in Kidney Transplant With no Steroids

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Kidney transplant patients will be treated with Thymoglobulin (5 days), tacrolimus (Prograf), and mycophenolate mofetil (Cellcept) from the time of transplant. They will only receive steroids for 4 days and no prednisone after that. At 1 month, they will have a kidney biopsy and if it is ok, patients will be treated long term with either continued tacrolimus/mycophenolate mofetil or be switched to sirolimus (Rapamune)/mycophenolate mofetil. This will be done randomly in a manner similar to flipping a coin. The investigators are trying to determine if after the initial therapy patients can stay off steroids long term and get better kidney function if they are treated with sirolimus compared to tacrolimus. Patients will be followed for 3 years and will repeat kidney biopsies at 1 and 2 years after transplant.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: Genzyme, a Sanofi Company; Raymond Heilman; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Mycophenolate mofetil; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

1. Primary deceased or living donor renal transplant recipients

2. Re-transplant recipients for which the first kidney transplant was lost for technical reasons with no sensitization (panel-reactive antibody [PRA] < 20%) or 1st lost due to recurrent disease, that is not steroid responsive.

3. Age > 18

4. Negative pregnancy test if female and of childbearing age. In addition, females of childbearing age must agree to use effective contraception for the duration of the study.

5. Patient must sign informed consent prior to transplant.