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

NCT06047106 | Recruiting

• 2 other identifiers: 69HCL23_03242023-A01402-43
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Living Donor Donation; multiparametric MRI; ischemia reperfusion injury; kidney graft

Outcome Measures

Primary Outcomes (1)

• Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence

  Baseline before transplantation, one month and 12 months after kidney transplantation

Secondary Outcomes (3)

• In recipients, R2* values measured by BOLD MRI

  Baseline before transplantation, one month and 12 months after kidney transplantation

• In recipients, T2 Values measured by T2 mapping MRI

  Baseline before transplantation, one month and 12 months after kidney transplantation

• In recipients, T1 Values measured by T1 mapping MRI

  Baseline before transplantation, one month and 12 months after kidney transplantation

Study Arms (2)

Living kidney donor

EXPERIMENTAL

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

Radiation: multiparametric MRI; Biological: blood samples; Biological: urine specimens

Recipient of kidney transplant from living donor

EXPERIMENTAL

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

Radiation: multiparametric MRI; Procedure: kidney graft biopsy; Biological: blood samples; Biological: urine specimens

Interventions

multiparametric MRI 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.

Living kidney donor; Recipient of kidney transplant from living donor

kidney graft biopsy PROCEDURE

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

Recipient of kidney transplant from living donor

blood samples 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).

Living kidney donor; Recipient of kidney transplant from living donor

urine specimens 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).

Living kidney donor; Recipient of kidney transplant from living donor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot, Hospices Civils de Lyon

Lyon, LYON, 69003, France

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Reperfusion Injury

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Sandrine LEMOINE, PU-PH

  Service de néphrologie à l'Hôpital Edouard Herriot

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandrine LEMOINE, PU-PH

CONTACT

04 72 11 02 44; sandrine.lemoine01@chu-lyon.fr

Marine GIRERD

CONTACT

04 72 11 06 20; marine.girerd@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Monocentric, Prospective, Non-randomized, Exploratory Study

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: May 7, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)