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Observation Study for Prediction of Allograft Survival and Impact of Imaging in Kidney Transplant Recipients.

Prospective Monocentric Observational Study of Kidney Transplant Recipients at the CHU of Liege for the Prediction of Allograft Survival and Impact of Imaging in Clinical Decision-making.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03764124
Enrollment
1000
Registered
2018-12-04
Start date
2007-01-01
Completion date
2024-08-31
Last updated
2024-05-09

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

Conditions

Kidney Transplantation

Keywords

Allograft survival, PET/CT imaging, Corticoids withdrawal, Bone mineral Density

Brief 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

Detailed 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.

Interventions

DIAGNOSTIC_TESTPET/CT imaging

The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events were applied.

Sponsors

University of Liege
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* Kidney recipient transplanted after 2007 * Kidney recipient over 18 years of age * Clinical, biological, immunological and follow up data available

Exclusion criteria

* Combined transplantation

Design outcomes

Primary

MeasureTime frameDescription
ImagingPrediction of rejection at time of biopsiesPrediction model of the PET/CT imaging to predict the histological results of a biopsy.

Secondary

MeasureTime frameDescription
Allograft survival probability post transplantationAllograft survival probability at 1-year post transplantationAllograft survival probability calculated from clinical, histological, immunological, and functional variables assessed at the time of transplant and at the time of biopsy at 3-months post transplant.
RejectionEvaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantationRisk of rejection rate in patients with corticosteroids withdrawal at 3 months.

Countries

Belgium

Contacts

Primary ContactAntoine Bouquegneau, MD
antoine.bouquegneau@gmail.com0032473353321
Backup ContactLaurent Weekers, MD
l.weekers@chuliege.be

Outcome results

None listed

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