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
1 other identifier
observational
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2013
CompletedFirst Posted
Study publicly available on registry
November 13, 2013
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedMay 26, 2016
May 1, 2016
1.9 years
October 31, 2013
May 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Allograft interstitial fibrosis (scored according to revised Banff 1997 criteria) in consecutive protocol biopsies
24 months post-transplantation
Secondary Outcomes (5)
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 concentration
24 months post-transplantation
Intra-graft expression of CTGF
24 months post-transplantation
Urinary markers of tubular injury and dysfunction
24 months post-transplantation
Study Arms (1)
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
Eligibility Criteria
Adult recipients of a primary or secondary cadaveric or living donor single renal allograft at the University Hospitals Leuven.
You may qualify if:
- Patients who receive a primary or secondary single cadaveric or living donor renal allograft.
- Signed informed consent
You may not qualify if:
- Patients receiving a combined renal allograft.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Biospecimen
whole blood, serum, urine, renal allograft tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dirk Kuypers, MD, PhD
Laboratory of Nephrology, University Hospitals Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Thomas Vanhove
Study Record Dates
First Submitted
October 31, 2013
First Posted
November 13, 2013
Study Start
July 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2019
Last Updated
May 26, 2016
Record last verified: 2016-05