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

NCT03764124 | Recruiting

• 1 other identifier: Liège KO
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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. 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. 2.To develop a prognostic risk score to predict kidney allograft survival;
3. 3.To evaluate the impact of corticoids withdrawal on long term outcomes (risk of rejection and impact on bone mineral density);
4. 4.Evaluate the type and the frequencies of complications in our kidney transplant population

Conditions

Kidney Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Imaging

  Prediction model of the PET/CT imaging to predict the histological results of a biopsy.

  Prediction of rejection at time of biopsies

Secondary Outcomes (2)

• Allograft survival probability post transplantation

  Allograft survival probability at 1-year post transplantation

• Rejection

  Evaluation of the risk of rejection during follow-up in patients with corticoids withdrawal at 3 months post transplantation

Study Arms (1)

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

Interventions

PET/CT imaging DIAGNOSTIC_TEST

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.

Kidney recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Combined transplantation

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

RECRUITING

Study Officials

• FRANCOIS JOURET, PhD

  CHU Liege department of Nephrology-Dialysis and Transplantation, and Groupe Interdisciplinaire de Géno-protéomique Appliquée, Cardiovascular Sciences.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Bouquegneau, MD

CONTACT

0032473353321; antoine.bouquegneau@gmail.com

Laurent Weekers, MD

CONTACT

l.weekers@chuliege.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 4, 2018
• Study Start: January 1, 2007
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)