Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether urinary connective tissue growth factor (uCTGF) can predict the onset of fibrosis in transplanted kidneys.

Detailed Description
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Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database (Biopsy Database), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database. All clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected. All renal allograft biopsies will be scored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database (Biopsy Database).

Official Title
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Prospective Study of Urinary Connective Tissue Growth Factor and Related Pro-fibrotic Mediators as Potential Early Biomarkers of Progressive Renal Allograft Fibrosis in de Novo Kidney Recipients

Conditions
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Kidney Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who receive a primary or secondary single cadaveric or living donor renal allograft. Signed informed consent Exclusion Criteria: Patients receiving a combined renal allograft.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Kidney transplant recipients<br>Adult recipients of a primary or secondary cadaveric or living donor single renal allograft at the University Hospitals Leuven between July 2014 and June 2016 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies |  | 24 months post-transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft function (eGFR, calculated with the Modification of Diet in Renal Disease formula) |  | 24 months post-transplantation | 
| Proteinuria (measured as g/g creatinine in a 24-hr urine collection) |  | 24 months post-transplantation | 
| Urinary CTGF concentration |  | 24 months post-transplantation | 
| Intra-graft expression of CTGF |  | 24 months post-transplantation | 
| Urinary markers of tubular injury and dysfunction |  | 24 months post-transplantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fibrosis, kidney transplantation, connective tissue growth factor