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

Renal Transplantation Clinical Trial

— RENALIFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024229
• Other study ID #: PHAO15/FB-RENALIFE
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: January 14, 2020

Study information

• Verified date: January 2020
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 14, 2020
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Device:
• LifePort® perfusion machine
Renal perfusion on LifePort® machine

Locations

Country	Name	City	State
France	CHR-ORLEANS Service d'Urologie	Orléans	Loiret
France	Urology CHRU-TOURS	Tours	I&L

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Laboratory of Biochemistry, University François Rabelais of TOURS

Country where clinical trial is conducted

France, 

Outcome

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