Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01982903
• Other study ID #: s55992
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2013
• Last updated: May 25, 2016
• Start date: July 2015
• Est. completion date: June 2019

Study information

• Verified date: May 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Thomas Vanhove, MD
• Phone: +32 27055733
• Email: thomas.vanhove[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 2019
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies		24 months post-transplantation	No
Secondary	Graft function (eGFR, calculated with the Modification of Diet in Renal Disease formula)		24 months post-transplantation	No
Secondary	Proteinuria (measured as g/g creatinine in a 24-hr urine collection)		24 months post-transplantation	No
Secondary	Urinary CTGF concentration		24 months post-transplantation	No
Secondary	Intra-graft expression of CTGF		24 months post-transplantation	No
Secondary	Urinary markers of tubular injury and dysfunction		24 months post-transplantation	No