Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.

NCT ID: NCT06047106

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-07
• Study Completion Date: 2027-09-30

Brief Summary

The selection of kidneys from living donors is based on strict glomerular filtration rate (GFR) values, in the setting of the increasing proportion of older donors. The 2017 KDIGO recommendations consider that approving kidney donation for a donor with a GFR between 60 and 89 mL/min/1.73 m² should be individually discussed, possibly using a calculator. A GFR < 60 mL/min/1.73 m² should contraindicate donation without considering the donor's age.

GFR physiologically decreases with age, so older donors frequently have a GFR below 90 ml/min/1.73 m². However, the proportion of older donors continues to rise.

Kidney grafts from older living donors maintain better renal function than those from deceased donors, aiming to counteract the organ shortage.

Kidneys possess functional reserves, allowing an increase in GFR during stimulations and adaptation to reduced functional nephron count (as after nephrectomy). Assessing this adaptive capacity clinically is challenging. It might be dependent on vascularization and/or absence of fibrosis, but these parameters are poorly understood due to a lack of current in vivo exploration methods.

The development of functional renal MRI enables the evaluation of these parameters, allowing measurements on separate, regional, non-invasive, quantitative kidney segments coupled with morphological studies. BOLD-MRI can measure regional oxygen content, thus accessing more precise medullary data. The DWI sequence can estimate renal microstructure and study interstitial fibrosis.

Therefore, evaluating renal performance (by measuring GFR, renal perfusion, fibrosis, inflammation, and oxygen content) in donors, and studying the evolution of these parameters in recipients and donors, could optimize donor selection.

Hence, the aim of our study is to 1) investigate the evolution of renal functional parameters in the transplanted kidney up to 1 year post-transplant, and 2) study the evolution of these same parameters in the contralateral kidney of the donor.

Conditions

Renal Insufficiency, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Living kidney donor

Patient eligible for living kidney donation with eGFR \> 60 ml/min/1.73m²

Group Type: EXPERIMENTAL

multiparametric MRI

Intervention Type: RADIATION

For the living donor, multiparametric MRI will be added in the day hospital: at the pre-transplant assessment and at the 12-month post-transplant assessment.

For the recipient: multiparametric MRI will be added in the day hospital at the time of the systematic assessment at 1 month post-transplant, and will be added in the day hospital at the time of the 12-month post-transplant assessment.

blood samples

Intervention Type: BIOLOGICAL

For donors who are not selected to donate their kidney, a total of 4 mL of blood will be collected at inclusion.

For donors eligible to donate, a total of 8 mL of blood will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 32 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).

urine specimens

Intervention Type: BIOLOGICAL

For donors who are not selected to donate their kidney, a total of 15 mL of urine will be collected at inclusion.

For donors eligible to donate, a total of 50 mL of urine will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 65 mL of urine will be collected (pre-transplant, 1 month and 12 months post-transplant).

Recipient of kidney transplant from living donor

Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor

Group Type: EXPERIMENTAL

multiparametric MRI

Intervention Type: RADIATION

For the living donor, multiparametric MRI will be added in the day hospital: at the pre-transplant assessment and at the 12-month post-transplant assessment.

For the recipient: multiparametric MRI will be added in the day hospital at the time of the systematic assessment at 1 month post-transplant, and will be added in the day hospital at the time of the 12-month post-transplant assessment.

kidney graft biopsy

Intervention Type: PROCEDURE

Biopsy of the graft itself prior to transplantation in the recipient.

blood samples

Intervention Type: BIOLOGICAL

For donors who are not selected to donate their kidney, a total of 4 mL of blood will be collected at inclusion.

For donors eligible to donate, a total of 8 mL of blood will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 32 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).

urine specimens

Intervention Type: BIOLOGICAL

For donors who are not selected to donate their kidney, a total of 15 mL of urine will be collected at inclusion.

For donors eligible to donate, a total of 50 mL of urine will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 65 mL of urine will be collected (pre-transplant, 1 month and 12 months post-transplant).

Interventions

multiparametric MRI

For the living donor, multiparametric MRI will be added in the day hospital: at the pre-transplant assessment and at the 12-month post-transplant assessment.

For the recipient: multiparametric MRI will be added in the day hospital at the time of the systematic assessment at 1 month post-transplant, and will be added in the day hospital at the time of the 12-month post-transplant assessment.

Intervention Type: RADIATION

kidney graft biopsy

Biopsy of the graft itself prior to transplantation in the recipient.

Intervention Type: PROCEDURE

blood samples

For donors who are not selected to donate their kidney, a total of 4 mL of blood will be collected at inclusion.

For donors eligible to donate, a total of 8 mL of blood will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 32 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).

Intervention Type: BIOLOGICAL

urine specimens

For donors who are not selected to donate their kidney, a total of 15 mL of urine will be collected at inclusion.

For donors eligible to donate, a total of 50 mL of urine will be collected (at inclusion and at 12 months post-transplant).

For recipients, a total of 65 mL of urine will be collected (pre-transplant, 1 month and 12 months post-transplant).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

For recipients:

• Patients with end-stage chronic kidney disease awaiting kidney transplant from a living donor.
• Adult patient
• Consent signed
• effective contraceptive method for women
• Patient affiliated to a social security or beneficiaries of a similar scheme

For donors:

• Individuals eligible for living kidney donation with GFR > 60 mL/min/1.73 m².
• Adult patient
• Consent signed
• effective contraceptive method for women
• Patient affiliated to a social security or beneficiaries of a similar scheme

Exclusion Criteria

For the two groups :

• MRI contraindications (claustrophobia, pacemaker, cardioverter defibrillators implantable, mechanical heart valve non MRI-compatible)
• Weight> 130 kg
• Pregnant, parturient or breastfeeding
• Persons deprived of their liberty by a judicial or administrative decision,
• Adults subject to a legal protection measure (safeguard measure, guardianship, curators)
• subject participating in another research including an exclusion period still in progress at inclusion

For recipients :

• Contraindication to renal graft biopsy (ongoing or uninterrupted anticoagulant or antiplatelet treatment, thrombocytopenia <100 x 10^9/L, anemia <7 g/dL).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandrine LEMOINE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Service de néphrologie à l'Hôpital Edouard Herriot

Locations

Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, LYON, France

Site Status: RECRUITING

Countries

France

Central Contacts

Sandrine LEMOINE, PU-PH

Role: CONTACT

sandrine.lemoine01@chu-lyon.fr

04 72 11 02 44

Marine GIRERD

Role: CONTACT

marine.girerd@chu-lyon.fr

04 72 11 06 20

Facility Contacts

SANDRINE PU-PH LEMOINE

Role: primary

sandrine.lemoine01@chu-lyon.fr

0687947771 ext. +33

Other Identifiers

2023-A01402-43

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL23_0324

Identifier Type: -

Identifier Source: org_study_id