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Completed

NCT Number: NCT03024229

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

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.

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Key information

Conditions

Renal Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Urology CHRU-TOURS, Tours, I&L, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LifePort® perfusion machine

Device

Renal perfusion on LifePort® machine

Primary outcomes

  1. IGF

    Time frame: 7 days

    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.

Secondary outcomes

  1. DGF

    Time frame: 7 days

    DGF Delayed graft function : Dialysis need within 7 days post-transplant

  2. BANFF-1

    Time frame: PRE-OPERATIONAL

    Anatomo-pathological classification of the pre-implantation biopsy according to the revised Banff classification 2013

  3. BANFF-2

    Time frame: 3 months

    Anatomo-pathological classification of systematic biopsy at 3 months post-transplant according to the revised Banff classification 2013

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Laboratory of Biochemistry, University François Rabelais of TOURS

Registry information

Official study title

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

Acronym: RENALIFE

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jan 18, 2017
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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