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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01860183
Other study ID # CHMerkur
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 2013
Est. completion date June 1, 2016

Study information

Verified date January 2014
Source Clinical Hospital Merkur
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date June 1, 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Mycophenolate mofetil
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.

Locations

Country Name City State
Croatia Clinical Hospital Merkur Zagreb HR

Sponsors (3)

Lead Sponsor Collaborator
Clinical Hospital Merkur University Hospital Rijeka, University Medical Centre Ljubljana

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Other Frequency of infections requiring hospitalization 1 year
Other Frequency of CMV viremia 1 year
Other Frequency of BK viremia 1 year
Other Frequency of BK nephropathy 1 year
Other Development of donor-specific antibodies 1 year
Other Renal morphology and hemodynamics assessed by ultrasound Subset of study patients 1 year
Primary Progression of interstitial fibrosis (ci) 1 year
Secondary Estimated glomerular filtration rate 1 year
Secondary Time to first acute rejection episode up to 1 year
Secondary Progression of other chronic scores 1 year
Secondary Graft loss 1 year
Secondary Patient survival 1 year
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