Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

Study Overview
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Brief Summary
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This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

Official Title
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The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Drug: Tacrolimus
* Drug: MMF
* Drug: Corticosteroids (Prednisone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods Exclusion Criteria: Recipients of a kidney from a donor over 65 years of age Recipient of non-related donor kidney with peak pre-transplant PRA > 50 Subject has lost a previous graft to rejection less than one year from transplant Subject who has received an investigational drug within three months prior to randomization Subjects who are pregnant or breastfeeding Subject receives a kidney lacking a pre-implantation biopsy Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Protocol biopsies at 1, 2 and 3 months | Drug: Tacrolimus<br>* Oral<br>* Other names: FK506;Drug: MMF<br>* Oral<br>* Other names: Cellcept;Drug: Corticosteroids (Prednisone)<br>* Oral<br>* Other names: Prednisone;|
| Active Comparator: 2<br>No protocol biopsies | Drug: Tacrolimus<br>* Oral<br>* Other names: FK506;Drug: MMF<br>* Oral<br>* Other names: Cellcept;Drug: Corticosteroids (Prednisone)<br>* Oral<br>* Other names: Prednisone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of subclinical rejection at 6 months |  | 6 months | 
| Prevalence of chronic renal histopathology at 24 months |  | 24 months | 
| Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion |  | 6, 12 and 24 moths | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplantation, Tacrolimus, Immunosuppression, Graft Survival