Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
- Conditions
- Kidney TransplantationKidney Failure
- Interventions
- Registration Number
- NCT01860183
- Lead Sponsor
- Clinical Hospital Merkur
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- first kidney or kidney-pancreas transplantation
- CDC PRA <=20%
- dual kidney transplantation
- AB0 incompatible transplantation
- 0 biopsy ci, ct, cv, or ah score >=2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MMF 3g daily Mycophenolate mofetil - MMF 2 g daily Mycophenolate mofetil -
- Primary Outcome Measures
Name Time Method Progression of interstitial fibrosis (ci) 1 year
- Secondary Outcome Measures
Name Time Method Estimated glomerular filtration rate 1 year Time to first acute rejection episode up to 1 year Progression of other chronic scores 1 year Graft loss 1 year Patient survival 1 year
Trial Locations
- Locations (1)
Clinical Hospital Merkur
ðŸ‡ðŸ‡·Zagreb, HR, Croatia