NCT06047106

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	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.
PROCEDURE	kidney graft biopsy	Biopsy of the graft itself prior to transplantation in the recipient.
BIOLOGICAL	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).
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).

Timeline

• Start date: 2024-05-07
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2023-09-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: France