Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants
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|ClinicalTrials.gov Identifier: NCT01982903|
Recruitment Status : Unknown
Verified May 2016 by Dr Thomas Vanhove, Universitaire Ziekenhuizen KU Leuven.
Recruitment status was: Recruiting
First Posted : November 13, 2013
Last Update Posted : May 26, 2016
|Condition or disease|
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").
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||180 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||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|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2019|
Kidney transplant recipients
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
- Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies [ Time Frame: 24 months post-transplantation ]
- Graft function (eGFR, calculated with the Modification of Diet in Renal Disease formula) [ Time Frame: 24 months post-transplantation ]
- Proteinuria (measured as g/g creatinine in a 24-hr urine collection) [ Time Frame: 24 months post-transplantation ]
- Urinary CTGF concentration [ Time Frame: 24 months post-transplantation ]
- Intra-graft expression of CTGF [ Time Frame: 24 months post-transplantation ]
- Urinary markers of tubular injury and dysfunction [ Time Frame: 24 months post-transplantation ]
Biospecimen Retention: Samples With DNA
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): NCT01982903
|Contact: Thomas Vanhove, MD||+32 firstname.lastname@example.org|
|Contact: Dirk Kuypers, MD, PhD||+32 email@example.com|
|University Hospitals Leuven||Recruiting|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Contact: Thomas Vanhove, MD +32 27055733 firstname.lastname@example.org|
|Principal Investigator:||Dirk Kuypers, MD, PhD||Laboratory of Nephrology, University Hospitals Leuven|