Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
Development of chronic changes (scarring) in transplanted kidney tissue is a major cause of
long-term kidney function deterioration and ultimately graft loss. It results from both
immunologic and non-immunologic mechanisms. Mycophenolate mofetil (MMF) is immunosuppressive
drug used for prevention of rejection after kidney transplant, usually in combination with a
calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. Besides
immunosuppression, MMF may also have direct antifibrotic properties. Tacrolimus has potent
immunosuppressive effects and is the cornerstone of contemporary posttransplant
immunosuppressive therapy in kidney recipients. However, it is also nephrotoxic. The
hypothesis of the present study is that in the setting of similar net immunosuppression,
higher dose of MMF (3 g daily) will result in slower progression of kidney fibrosis during
first year posttransplant as compared to MMF 2 g daily. To test this hypothesis, the present
study will randomly assign low immunological risk kidney transplant recipients to either 2g
or 3 g MMF daily, in combination with tacrolimus, with, or without maintenance steroids. All
patients will have kidney biopsy at implantation and at 12 months after transplantation. Main
outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by
protocol biopsy.
Phase:
Phase 4
Details
Lead Sponsor:
Clinical Hospital Merkur
Collaborators:
Clinical Hospital Centre Osijek University Hospital Rijeka University Medical Centre Ljubljana