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
1 other identifier
interventional
40
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2017
CompletedFirst Posted
Study publicly available on registry
January 18, 2017
CompletedStudy Start
First participant enrolled
March 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2020
CompletedDecember 23, 2025
December 1, 2025
2.5 years
January 12, 2017
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
DGF
7 days
BANFF-1
PRE-OPERATIONAL
BANFF-2
3 months
Study Arms (1)
LifePort® perfusion machine
OTHERMetabolomic 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Urology CHRU-TOURS
Tours, I&L, 37000, France
CHR-ORLEANS Service d'Urologie
Orléans, Loiret, 45100, France
Related Publications (1)
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.
PMID: 35442245RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Franck BRUYERE, MD-PhD
University François Rabelais of TOURS
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2017
First Posted
January 18, 2017
Study Start
March 15, 2017
Primary Completion
September 15, 2019
Study Completion
January 14, 2020
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share