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.

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

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplantation
• Intervention / Treatment: Diagnostic test: PET/CT imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Laurent Weekers, MD; Email: l.weekers@chuliege.be
• Study Contact Backup: Name: Antoine Bouquegneau, MD; Phone Number: 0032473353321; Email: antoine.bouquegneau@gmail.com

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • Centre Hospitalier Universitaire de Liege
    • Contact: Antoine Bouquegneau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Kidney recipients aged over 18 of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire of Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Kidney recipients; Kidney recipients aged over 18 and of all sexes recruited between 2007 and 2020 from the Centre Hospitalier Universitaire de Liege, who have e-GFR follow-up and data from protocol and for cause biopsies available at 1-year post transplant. PET/CT imaging will be performed with patient's approval for protocol and per cause biopsies we performed. Data will be collected in the follow up such as clinical, biological and histological data.

Diagnostic test: PET/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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging	Prediction model of the PET/CT imaging to predict the histological results of a biopsy.	Prediction of rejection at time of biopsies

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allograft survival probability post transplantation	Allograft 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.	Allograft survival probability at 1-year post transplantation
Rejection	Risk of rejection rate in patients with corticosteroids withdrawal at 3 months.	Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: FRANCOIS JOURET, PhD, CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2007
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Allograft survival; PET/CT imaging; Corticoids withdrawal; Bone mineral Density
• Other Study ID Numbers: Liège KO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No