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

Renal Insufficiency, Chronic Clinical Trial

— DOVIMIR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047106
• Other study ID #: 69HCL23_0324
• Secondary ID: 2023-A01402-43
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2024
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: Sandrine LEMOINE, PU-PH
• Phone: 04 72 11 02 44
• Email: sandrine.lemoine01[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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 2 mL of blood will be collected at inclusion. For donors eligible to donate, a total of 4 mL of blood will be collected (at inclusion and at 12 months post-transplant). For recipients, a total of 26 mL of blood will be collected (pre-transplant, 1 month and 12 months post-transplant).
• 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).

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot, Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence		Baseline before transplantation, one month and 12 months after kidney transplantation
Secondary	In recipients, R2* values measured by BOLD MRI		Baseline before transplantation, one month and 12 months after kidney transplantation
Secondary	In recipients, T2 Values measured by T2 mapping MRI		Baseline before transplantation, one month and 12 months after kidney transplantation
Secondary	In recipients, T1 Values measured by T1 mapping MRI		Baseline before transplantation, one month and 12 months after kidney transplantation