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:
Participant gender:
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
Details
Lead Sponsor:
Mayo Clinic
Collaborators:
Genzyme, a Sanofi Company Raymond Heilman Wyeth is now a wholly owned subsidiary of Pfizer