Clinical trial NCT01860183: Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
Official title: Comparison of 3g Versus 2g Mycophenolate Mofetil in Combination With Tacrolimus on Progression of Chronic Histology Changes in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Kidney Failure
Keywords: kidney transplantation
chronic allograft dysfunction
mycophenolate mofetil
Chronic
Lead sponsor: Clinical Hospital Merkur
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
name: University Hospital Rijeka
First posted: 2013-05-22
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. first kidney or kidney-pancreas transplantation
2. CDC PRA \<=20%

Exclusion Criteria:

1. dual kidney transplantation
2. AB0 incompatible transplantation
3. 0 biopsy ci, ct, cv, or ah score \>=2

Primary outcomes:
measure: Progression of interstitial fibrosis (ci)
timeFrame: 1 year
Secondary outcomes:
measure: Estimated glomerular filtration rate
timeFrame: 1 year
measure: Time to first acute rejection episode
timeFrame: up to 1 year
measure: Progression of other chronic scores
timeFrame: 1 year
measure: Graft loss
timeFrame: 1 year
measure: Patient survival
timeFrame: 1 year
Other outcomes:
measure: Frequency of infections requiring hospitalization
timeFrame: 1 year
measure: Frequency of CMV viremia
timeFrame: 1 year
measure: Frequency of BK viremia
timeFrame: 1 year
measure: Frequency of BK nephropathy
timeFrame: 1 year
measure: Development of donor-specific antibodies
timeFrame: 1 year
measure: Renal morphology and hemodynamics assessed by ultrasound
timeFrame: 1 year
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
state: HR
Study officials:
References: