Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants

• Conditions: Kidney Failure

• Registration Number: NCT01982903
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-13
• Study Start: 2015-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26
• Primary Completion: 2017-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies	24 months post-transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium