Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants

NCT ID: NCT01982903

Last Updated: 2016-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2019-06-30

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").

Conditions

Kidney Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Dr Thomas Vanhove

Dr Thomas Vanhove

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk Kuypers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Nephrology, University Hospitals Leuven

Locations

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Thomas Vanhove, MD

Role: CONTACT

thomas.vanhove@uzleuven.be

+32 27055733

Dirk Kuypers, MD, PhD

Role: CONTACT

dirk.kuypers@uzleuven.be

+32 16344595

Facility Contacts

Thomas Vanhove, MD

Role: primary

thomas.vanhove@uzleuven.be

+32 27055733

Other Identifiers

s55992

Identifier Type: -

Identifier Source: org_study_id