Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03764124 |
| Other study ID # |
Liège KO |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2007 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
May 2024 |
| Source |
University of Liege |
| Contact |
Antoine Bouquegneau, MD |
| Phone |
0032473353321 |
| Email |
antoine.bouquegneau[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To further develop personalized medicine in kidney transplantation and improve transplant
patient outcomes, attention has been given to define early surrogate endpoints that might aid
therapeutic interventions, and help clinical decision-making.
To adequately predict transplant patients' individual risks of allograft loss and patients'
complications, this would require a complex integration of data, including: donor data,
recipient characteristics, transplant characteristics, biopsies results, immunosuppressive
regimen, allograft infections, acute kidney injuries, recipient immune profiles, protocol and
per cause biopsies and imaging (PET/CT imaging).
This project aims:
1. Assessed the usefulness of 18F-FDG PET/CT imaging in kidney transplantation recipients
presenting with suspected acute rejection who underwent a transplant needle biopsy;
2. To develop a prognostic risk score to predict kidney allograft survival;
3. To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection
and impact on bone mineral density);
4. Evaluate the type and the frequencies of complications in our kidney transplant
population
Description:
1. The detection of acute rejection in kidney transplant recipients, depends critically on
assessments of serum creatinine, an insensitive measure of renal injury and the
diagnosis relies on renal transplant needle biopsy which is an invasive procedure
associated with a significant risk of bleeding and graft loss and is limited by sampling
error and/or interobserver variability. Moreover, repeated biopsies to evaluate a renal
graft's status pose challenges, including practicability and cost. Consequently, other
sensitive and less invasive modalities, including gene expression profiling and omic
analyses of blood and urine samples as well as in vivo imaging, are currently under
investigation to reinforce our clinical armamentarium for acute rejection diagnosis.
Likewise, it would be useful to non-invasively predict rejection in kidney transplant
recipients with acute renal dysfunction and suspected acute rejection, thereby avoiding
unnecessary transplant biopsy.
2. This study aims to generate a scoring system that predicts individual patients' risk of
long-term kidney allograft failure.
3. Since 2007, the protocol in our institution is to withdraw the corticoids after 3 months
after the protocol biopsy if no sign of rejection is demonstrated. We would like to
evaluate the impact of such decision in the risk of rejection and the long-term
allograft outcome in our patients. We are looking also to the impact on bone mineral
density after corticoids withdrawal in those patients.
4. Evaluate the type and the frequencies of complications in our kidney transplant
population to adapt our daily basis clinical practice.
