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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860183
Recruitment Status : Unknown
Verified January 2014 by Clinical Hospital Merkur.
Recruitment status was:  Recruiting
First Posted : May 22, 2013
Last Update Posted : January 30, 2014
Sponsor:
Collaborators:
University Medical Centre Ljubljana
Clinical Hospital Centre Osijek
University Hospital Rijeka
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Kidney Failure Drug: Mycophenolate mofetil Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of 3g Versus 2g Mycophenolate Mofetil in Combination With Tacrolimus on Progression of Chronic Histology Changes in Kidney Transplant Recipients
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015


Arm Intervention/treatment
Experimental: MMF 3g daily 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.

Active Comparator: MMF 2 g daily 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.




Primary Outcome Measures :
  1. Progression of interstitial fibrosis (ci) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Estimated glomerular filtration rate [ Time Frame: 1 year ]
  2. Time to first acute rejection episode [ Time Frame: up to 1 year ]
  3. Progression of other chronic scores [ Time Frame: 1 year ]
  4. Graft loss [ Time Frame: 1 year ]
  5. Patient survival [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Frequency of infections requiring hospitalization [ Time Frame: 1 year ]
  2. Frequency of CMV viremia [ Time Frame: 1 year ]
  3. Frequency of BK viremia [ Time Frame: 1 year ]
  4. Frequency of BK nephropathy [ Time Frame: 1 year ]
  5. Development of donor-specific antibodies [ Time Frame: 1 year ]
  6. Renal morphology and hemodynamics assessed by ultrasound [ Time Frame: 1 year ]
    Subset of study patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860183


Contacts
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Contact: Mladen Knotek, MD +38512431393 mladen.knotek1@zg.t-com.hr
Contact: Bojana Maksimović, MD +38512431393 b.maximovic@gmail.com

Locations
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Croatia
Clinical Hospital Merkur Recruiting
Zagreb, HR, Croatia, 10000
Contact: Mladen Knotek, MD    385994888231    mladen.knotek1@zg.t-com.hr   
Contact: Bojana Maksimović, MD    +38512431393    b.maximovic@gmail.com   
Sponsors and Collaborators
Clinical Hospital Merkur
University Medical Centre Ljubljana
Clinical Hospital Centre Osijek
University Hospital Rijeka

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Responsible Party: Clinical Hospital Merkur
ClinicalTrials.gov Identifier: NCT01860183    
Other Study ID Numbers: CHMerkur
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014
Keywords provided by Clinical Hospital Merkur:
kidney transplantation
chronic allograft dysfunction
mycophenolate mofetil
Chronic
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents