NCT06047106 Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.
| NCT ID | NCT06047106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Renal Insufficiency, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-05-07 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2024-05-07 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Sandrine LEMOINE, PU-PH
PRINCIPAL INVESTIGATOR
Service de néphrologie à l'Hôpital Edouard Herriot
Frequently Asked Questions
Who can join the NCT06047106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Insufficiency, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047106 currently recruiting?
Yes, NCT06047106 is actively recruiting participants. Contact the research team at sandrine.lemoine01@chu-lyon.fr for enrollment information.
Where is the NCT06047106 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06047106 clinical trial?
NCT06047106 is sponsored by Hospices Civils de Lyon. The principal investigator is Sandrine LEMOINE, PU-PH at Service de néphrologie à l'Hôpital Edouard Herriot. The trial plans to enroll 80 participants.