Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine (RENALIFE)

The Importance of Metabolomics in Assessing the Quality of Kidney Transplants Retained on a LifePort® Perfusion Machine Before Renal Transplantation

When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

Study Overview

• Status: Completed
• Conditions: Renal Transplantation
• Intervention / Treatment: Device: LifePort® perfusion machine

Detailed Description

The quality of the renal transplant prior to transplantation is essential for the recovery of graft function in the days following transplantation and its long-term survival. When the kidneys are perfused on perfusion machines before transplantation, the resistance parameters as well as the histological score on the pre-implantation biopsy participate in the evaluation of the quality of the graft. The metabolomic profile of the infusion fluid could provide additional evidence.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • I&L
    • Tours, I&L, France, 37000
      • Urology CHRU-TOURS
  • Loiret
    • Orléans, Loiret, France, 45100
      • CHR-ORLEANS Service d'Urologie

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Donors aged 18 years or more in brain death or who died of cardiac arrest collected locally in Tours, associated with the major local recipients of the grafts over the same period.

Exclusion Criteria:

• Kidney transplant removed but stored in a static preservative.
• Kidney grafts of donors aged 18 years or more, removed and not retained on a LifePort® perfusion machine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LifePort® perfusion machine; Metabolomic analysis of the preservation fluid of the graft, donor and recipient urine by nuclear magnetic resonance spectroscopy, and if possible by liquid and gas chromatography coupled with mass spectrometry.	Device: LifePort® perfusion machine; Renal perfusion on LifePort® machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IGF	Immediate Graft Function (IGF), defined by serum creatinine less than 250 μM / L at day 7 post-kidney transplant, without requiring dialysis of the recipient patient.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DGF	DGF Delayed graft function : Dialysis need within 7 days post-transplant	7 days
BANFF-1	Anatomo-pathological classification of the pre-implantation biopsy according to the revised Banff classification 2013	PRE-OPERATIONAL
BANFF-2	Anatomo-pathological classification of systematic biopsy at 3 months post-transplant according to the revised Banff classification 2013	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: Laboratory of Biochemistry, University François Rabelais of TOURS
• Investigators: Principal Investigator: Franck BRUYERE, MD-PhD, University François Rabelais of TOURS

Publications and helpful links

General Publications

• Faucher Q, Alarcan H, Sauvage FL, Forestier L, Miquelestorena-Standley E, Nadal-Desbarats L, Arnion H, Venhard JC, Brichart N, Bruyere F, Marquet P, Barin-Le Guellec C. Perfusate Metabolomics Content and Expression of Tubular Transporters During Human Kidney Graft Preservation by Hypothermic Machine Perfusion. Transplantation. 2022 Sep 1;106(9):1831-1843. doi: 10.1097/TP.0000000000004129. Epub 2022 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimated): January 18, 2017

Study Record Updates

• Last Update Posted (Estimated): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Transplantation;perfusion machine
• Other Study ID Numbers: PHAO15/FB-RENALIFE

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