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Prospective Study of Urinary Markers of Fibrosis in Kidney Transplants

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ClinicalTrials.gov Identifier: NCT01982903
Recruitment Status : Recruiting
First Posted : November 13, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Thomas Vanhove, Universitaire Ziekenhuizen 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.

Condition or disease
Kidney Failure

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 Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
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 Start Date : July 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2019

Group/Cohort
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



Primary Outcome Measures :
  1. Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies [ Time Frame: 24 months post-transplantation ]

Secondary Outcome Measures :
  1. Graft function (eGFR, calculated with the Modification of Diet in Renal Disease formula) [ Time Frame: 24 months post-transplantation ]
  2. Proteinuria (measured as g/g creatinine in a 24-hr urine collection) [ Time Frame: 24 months post-transplantation ]
  3. Urinary CTGF concentration [ Time Frame: 24 months post-transplantation ]
  4. Intra-graft expression of CTGF [ Time Frame: 24 months post-transplantation ]
  5. Urinary markers of tubular injury and dysfunction [ Time Frame: 24 months post-transplantation ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, urine, renal allograft tissue


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01982903


Contacts
Contact: Thomas Vanhove, MD +32 27055733 thomas.vanhove@uzleuven.be
Contact: Dirk Kuypers, MD, PhD +32 16344595 dirk.kuypers@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Thomas Vanhove, MD    +32 27055733    thomas.vanhove@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Dirk Kuypers, MD, PhD Laboratory of Nephrology, University Hospitals Leuven

Responsible Party: Dr Thomas Vanhove, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01982903     History of Changes
Other Study ID Numbers: s55992
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016

Keywords provided by Dr Thomas Vanhove, Universitaire Ziekenhuizen Leuven:
kidney transplantation
connective tissue growth factor
fibrosis

Additional relevant MeSH terms:
Fibrosis
Renal Insufficiency
Pathologic Processes
Kidney Diseases
Urologic Diseases