Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis

Kidney Transplantation Clinical Trial

Official title:

Comparison of 3g Versus 2g Mycophenolate Mofetil in Combination With Tacrolimus on Progression of Chronic Histology Changes in Kidney Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860183
• Other study ID #: CHMerkur
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Kidney Failure
• Kidney Transplantation
• Renal Insufficiency

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