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Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01982903
Enrollment
180
Registered
2013-11-13
Start date
2015-07-31
Completion date
2019-06-30
Last updated
2016-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure

Keywords

kidney transplantation, connective tissue growth factor, fibrosis

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).

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies24 months post-transplantation

Secondary

MeasureTime 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 concentration24 months post-transplantation
Intra-graft expression of CTGF24 months post-transplantation
Urinary markers of tubular injury and dysfunction24 months post-transplantation

Countries

Belgium

Contacts

Primary ContactThomas Vanhove, MD
thomas.vanhove@uzleuven.be+32 27055733
Backup ContactDirk Kuypers, MD, PhD
dirk.kuypers@uzleuven.be+32 16344595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026