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

NCT ID: NCT03024229

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-15

Study Completion Date

2020-01-14

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Renal Transplantation

Keywords

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Transplantation;perfusion machine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Metabolic assessment in Urine and perfusion liquids
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

LifePort® perfusion machine

Intervention Type DEVICE

Renal perfusion on LifePort® machine

Interventions

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LifePort® perfusion machine

Renal perfusion on LifePort® machine

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laboratory of Biochemistry, University François Rabelais of TOURS

UNKNOWN

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck BRUYERE, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

University François Rabelais of TOURS

Locations

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Urology CHRU-TOURS

Tours, I&L, France

Site Status

CHR-ORLEANS Service d'Urologie

Orléans, Loiret, France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 35442245 (View on PubMed)

Other Identifiers

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PHAO15/FB-RENALIFE

Identifier Type: -

Identifier Source: org_study_id