Renal Insufficiency, ChronicDOVIMIRNCT06047106
Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation.
A study testing multiparametric MRI, kidney graft biopsy and blood samples in people with Renal Insufficiency, Chronic, run by Hospices Civils de Lyon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Chronic
- What is being tested?
- multiparametric MRI, kidney graft biopsy and blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2024to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
SANDRINE PU-PH LEMOINE, 0687947771 ext. +33, sandrine.lemoine01@chu-lyon.fr
About this study
Official title: DOVIMIR : Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation
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.
Read more
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
- Being tested
- multiparametric MRI, kidney graft biopsy, blood samples, urine specimens
- Keywords
- Living Donor Donation, multiparametric MRI, ischemia reperfusion injury, kidney graft
- Medical subject headings
- Renal Insufficiency, Chronic, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiparametric MRIRadiation
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.
kidney graft biopsyProcedure or surgery
Biopsy of the graft itself prior to transplantation in the recipient.
blood samplesBiological
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 specimensBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| Living kidney donor | Experimental | Patient eligible for living kidney donation with eGFR > 60 ml/min/1.73m² Receives: 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 Receives: Radiation: multiparametric MRI; Procedure: kidney graft biopsy; Biological: blood samples; Biological: urine specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence
Measured: Baseline before transplantation, one month and 12 months after kidney transplantation
Secondary outcomes (3)
In recipients, R2* values measured by BOLD MRI
Measured: Baseline before transplantation, one month and 12 months after kidney transplantation
In recipients, T2 Values measured by T2 mapping MRI
Measured: Baseline before transplantation, one month and 12 months after kidney transplantation
In recipients, T1 Values measured by T1 mapping MRI
Measured: Baseline before transplantation, one month and 12 months after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start7 May 2024
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, Prospective, Non-randomized, Exploratory Study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine LEMOINE, PU-PH, Principal investigator, Service de néphrologie à l'Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047106
- Sponsor's protocol ID
- 69HCL23_0324
- Other IDs
- 2023-A01402-43
- Acronym
- DOVIMIR
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOVIMIR : Multi-parametric MRI Evaluation of Renal Graft Performance After Living Donor Donation
- ClinicalTrials.gov ID
- NCT06047106
- Acronym / sponsor ID
- DOVIMIR / 69HCL23_0324
- Conditions
- Renal Insufficiency, Chronic
- Keywords
- Living Donor Donation, multiparametric MRI, ischemia reperfusion injury, kidney graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, Prospective, Non-randomized, Exploratory Study
| Arm | Type | Receives |
|---|---|---|
| Living kidney donor | Experimental | Radiation: multiparametric MRI, Biological: blood samples, Biological: urine specimensPatient eligible for living kidney donation with eGFR > 60 ml/min/1.73m² |
| Recipient of kidney transplant from living donor | Experimental | Radiation: multiparametric MRI, Procedure: kidney graft biopsy, Biological: blood samples, Biological: urine specimensPatient with end-stage chronic kidney failure awaiting kidney transplant from living donor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiparametric MRIFor 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. | Radiation | Living kidney donor, Recipient of kidney transplant from living donor |
| kidney graft biopsyBiopsy of the graft itself prior to transplantation in the recipient. | Procedure or surgery | Recipient of kidney transplant from living donor |
| blood samplesFor 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). | Biological | Living kidney donor, Recipient of kidney transplant from living donor |
| urine specimensFor 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). | Biological | Living kidney donor, Recipient of kidney transplant from living donor |
Primary outcome
Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence
Time frame: Baseline before transplantation, one month and 12 months after kidney transplantation
3 secondary outcomes
In recipients, R2* values measured by BOLD MRI
Time frame: Baseline before transplantation, one month and 12 months after kidney transplantation
In recipients, T2 Values measured by T2 mapping MRI
Time frame: Baseline before transplantation, one month and 12 months after kidney transplantation
In recipients, T1 Values measured by T1 mapping MRI
Time frame: Baseline before transplantation, one month and 12 months after kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandrine LEMOINE, PU-PH principal investigator
Service de néphrologie à l'Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multiparametric MRI, kidney graft biopsy and blood samples in people with Renal Insufficiency, Chronic, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandrine LEMOINE, PU-PH (04 72 11 02 44, sandrine.lemoine01@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apparent diffusion coefficient (ADC) coefficient values measured in diffusion-weighted MRI sequence (time frame: Baseline before transplantation, one month and 12 months after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.