Clinical trial NCT01982903: Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure
Keywords: kidney transplantation
connective tissue growth factor
fibrosis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult recipients of a primary or secondary cadaveric or living donor single renal allograft at the University Hospitals 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").

Eligibility criteria: 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.

Primary outcomes:
measure: Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies
timeFrame: 24 months post-transplantation
Secondary outcomes:
measure: Graft function (eGFR, calculated with the Modification of Diet in Renal Disease formula)
timeFrame: 24 months post-transplantation
measure: Proteinuria (measured as g/g creatinine in a 24-hr urine collection)
timeFrame: 24 months post-transplantation
measure: Urinary CTGF concentration
timeFrame: 24 months post-transplantation
measure: Intra-graft expression of CTGF
timeFrame: 24 months post-transplantation
measure: Urinary markers of tubular injury and dysfunction
timeFrame: 24 months post-transplantation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Laboratory of Nephrology, University Hospitals Leuven
name: Dirk Kuypers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: