NCT03024229

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2020

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

2.5 years

First QC Date

January 12, 2017

Last Update Submit

December 16, 2025

Conditions

Keywords

Transplantation;perfusion machine

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

OTHER

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

Interventions

Renal perfusion on LifePort® machine

LifePort® perfusion machine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

CHR-ORLEANS Service d'Urologie

Orléans, Loiret, 45100, France

Location

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.

Study Officials

  • Franck BRUYERE, MD-PhD

    University François Rabelais of TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Metabolic assessment in Urine and perfusion liquids
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

Locations