Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06047106

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

Led by Hospices Civils de Lyon · Updated on 2026-01-21

60

Participants Needed

1

Research Sites

173 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with end-stage chronic kidney disease awaiting kidney transplant from a living donor
  • Adult patients
  • Signed informed consent
  • Effective contraceptive method for women
  • Affiliated to social security or similar scheme
  • Individuals eligible for living kidney donation with GFR > 60 mL/min/1.73 m²
  • Adult patients
  • Signed informed consent
  • Effective contraceptive method for women
  • Affiliated to social security or similar scheme
Not Eligible

You will not qualify if you...

  • Contraindications to MRI, including claustrophobia, pacemaker, implantable cardioverter defibrillator, or non-MRI-compatible mechanical heart valve
  • Weight over 130 kg
  • Pregnant, parturient, or breastfeeding
  • Persons deprived of liberty by judicial or administrative decision
  • Adults under legal protection measures (safeguard, guardianship, curatorship)
  • Participation in another research study with an exclusion period still active at inclusion
  • For recipients: contraindications to kidney graft biopsy such as ongoing anticoagulant or antiplatelet treatment, thrombocytopenia below 100 x 10^9/L, or anemia below 7 g/dL

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, LYON, France, 69003

Actively Recruiting

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Research Team

S

Sandrine LEMOINE, PU-PH

CONTACT

M

Marine GIRERD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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