Back to resultsEffect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
Primary Purpose
Kidney Transplantation, Kidney Failure
Status
Completed
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
Mycophenolate mofetil
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Transplantation focused on measuring kidney transplantation, chronic allograft dysfunction, mycophenolate mofetil, Chronic
Eligibility Criteria
Inclusion Criteria:
- first kidney or kidney-pancreas transplantation
- CDC PRA <=20%
Exclusion Criteria:
- dual kidney transplantation
- AB0 incompatible transplantation
- 0 biopsy ci, ct, cv, or ah score >=2
Sites / Locations
- Clinical Hospital Merkur
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MMF 3g daily
MMF 2 g daily
Arm Description
Outcomes
Primary Outcome Measures
Progression of interstitial fibrosis (ci)
Secondary Outcome Measures
Estimated glomerular filtration rate
Time to first acute rejection episode
Progression of other chronic scores
Graft loss
Patient survival
Full Information
NCT ID
NCT01860183
First Posted
May 18, 2013
Last Updated
October 18, 2021
Sponsor
Clinical Hospital Merkur
Collaborators
University Medical Centre Ljubljana, University Hospital Rijeka
1. Study Identification
Unique Protocol Identification Number
NCT01860183
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Hospital Merkur
Collaborators
University Medical Centre Ljubljana, University Hospital Rijeka
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Kidney Failure
Keywords
kidney transplantation, chronic allograft dysfunction, mycophenolate mofetil, Chronic
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MMF 3g daily
Arm Type
Experimental
Arm Title
MMF 2 g daily
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil
Intervention Description
Mycophenolate will be administered to all study patients at dose of 3 g daily for the first seven days posttransplant. Afterwards, study patients will continue, as randomized, on either 3 g, or 2 g MMF daily.
Primary Outcome Measure Information:
Title
Progression of interstitial fibrosis (ci)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Estimated glomerular filtration rate
Time Frame
1 year
Title
Time to first acute rejection episode
Time Frame
up to 1 year
Title
Progression of other chronic scores
Time Frame
1 year
Title
Graft loss
Time Frame
1 year
Title
Patient survival
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Frequency of infections requiring hospitalization
Time Frame
1 year
Title
Frequency of CMV viremia
Time Frame
1 year
Title
Frequency of BK viremia
Time Frame
1 year
Title
Frequency of BK nephropathy
Time Frame
1 year
Title
Development of donor-specific antibodies
Time Frame
1 year
Title
Renal morphology and hemodynamics assessed by ultrasound
Description
Subset of study patients
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first kidney or kidney-pancreas transplantation
CDC PRA <=20%
Exclusion Criteria:
dual kidney transplantation
AB0 incompatible transplantation
0 biopsy ci, ct, cv, or ah score >=2
Facility Information:
Facility Name
Clinical Hospital Merkur
City
Zagreb
State/Province
HR
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Learn more about this trial
Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
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