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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01402-43 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Living kidney donor | Experimental | Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m² |
|
| Recipient of kidney transplant from living donor | Experimental | Patient with end-stage chronic kidney failure awaiting kidney transplant from living donor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence | Baseline before transplantation, one month and 12 months after kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
For recipients:
For donors:
Exclusion Criteria:
For the two groups :
For recipients :
- Contraindication to renal graft biopsy (ongoing or uninterrupted anticoagulant or antiplatelet treatment, thrombocytopenia <100 x 10^9/L, anemia <7 g/dL).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Sandrine LEMOINE, PU-PH | Service de néphrologie à l'Hôpital Edouard Herriot | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Edouard Herriot, Hospices Civils de Lyon | Recruiting | Lyon | 69003 | France |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Monocentric, Prospective, Non-randomized, Exploratory Study
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|
| kidney graft biopsy | Procedure | Biopsy of the graft itself prior to transplantation in the recipient. |
|
| 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). |
|
| 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). |
|
| In recipients, T1 Values measured by T1 mapping MRI | Baseline before transplantation, one month and 12 months after kidney transplantation |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |