DOVIMIR : Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Recipient of kidney transplant from living donor
Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor
干预措施: kidney graft biopsy (Procedure)
Living kidney donor
Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m²
干预措施: multiparametric MRI (Radiation)
Living kidney donor
Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m²
干预措施: blood samples (Biological)
Living kidney donor
Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m²
干预措施: urine specimens (Biological)
Recipient of kidney transplant from living donor
Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor
干预措施: multiparametric MRI (Radiation)
Recipient of kidney transplant from living donor
Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor
干预措施: blood samples (Biological)
Recipient of kidney transplant from living donor
Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor
干预措施: urine specimens (Biological)
结局指标
主要结局
Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence
时间窗: Baseline before transplantation, one month and 12 months after kidney transplantation
次要结局
- In recipients, T2 Values measured by T2 mapping MRI(Baseline before transplantation, one month and 12 months after kidney transplantation)
- In recipients, R2* values measured by BOLD 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)