Interstitial Fibrosis/Tubular Atrophy of Transplanted KidneysNCT03918161
Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
A study testing MRE exam in people with Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys
- What is being tested?
- MRE exam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2019to 12 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18yrs;
- Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control;
- Signed informed consent;
- Affiliated or beneficiary of health insurance
Who cannot join
- Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (> 80%) on Doppler;
- Pregnant or nursing women;
- Contraindications to MRI;
- Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent
Trial locations and contacts
1 site in 1 country.
About this study
: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control.
The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.
Read the detailed description
The natural history of interstitial fibrosis/tubular atrophy (IF/TA) is a common mechanism of disease progression of transplanted kidneys. The process has been well studied through protocol biopsies. The early phase is characterized by fibrogenesis and the emergence of tubulo-interstitial damage due to immunologic phenomena; the late phase is characterized by the worsening of parenchymal lesions and the occurrence of glomerular sclerosis leading to graft loss.
Today, non-invasive markers of these pathological changes are missing and the protocol biopsies are still the only reliable tool for the diagnosis of IF/TA.
Elasticity imaging has already been proven in the management of chronic liver diseases with Fibroscan. In the field of renal diseases, several studies have been carried out in ultrasound elastography on renal grafts but the renal elastography is more difficult due to the complexity of the kidney (deep organ, two compartments, high vascularity). All these parameters have an influence on the elasticity measures.
The elastography imaging is also performed in MRI (Magnetic resonance imaging): The Magnetic Resonance Elastography (MRE). MRE is less subject to variations in depth, to the experience of the operator and to allow an overall evaluation of the graft.
The potentially eligible patients will be recruited by the nephrologist during a consultation in which renal biopsy is scheduled (as part of current practice). Patients meeting the inclusion criteria and having no exclusion criteria will be offered to participate in this study. If accepted, the only examination specific to this research, the MRE, will be scheduled to be performed the same day as the renal biopsy.
This MRE is painless, non-irradiating, and does not require the injection of contrast medium.
The participation of the patient ends when he leaves the hospital after the biopsy procedure.
- Being tested
- MRE exam
- Keywords
- Interstitial fibrosis, Tubular atrophy Renal transplantation, Renal allograft, Magnetic Resonance Imaging, Elastography, non-invasive diagnosis
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRE examDevice
Magnetic Resonance Elastography
| Study group | Role | What they receive |
|---|---|---|
| MRE exam | Experimental | Magnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences Receives: Device: MRE exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean value of renal elasticity
5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)
Measured: Baseline (defined as during MRE exam)
Secondary outcomes (1)
Average value of renal elasticity
measured in 10 areas of the graft Intra-renal inflammation, tubulitis, chronic vascular and glomerular lesions measured semi-quantitatively by the pathologist following the Banff classification
Measured: Baseline (defined as during MRE exam)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start24 Jul 2019
- Primary completion10 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Interstitial Fibrosis/Tubular Atrophy of Transplanted KidneysStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will realize Magnetic Resonance Elastography exam
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918161
- Sponsor's protocol ID
- CHUBX 2019/17
- Other IDs
- 2019-A00876-51
- Status last verified
- Mar 2021
- First submitted
- 12 Apr 2019
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chauveau B, Merville P, Soulabaille B, Taton B, Kaminski H, Visentin J, Vermorel A, Bouzgarrou M, Couzi L, Grenier N. Magnetic Resonance Elastography as Surrogate Marker of Interstitial Fibrosis in Kidney Transplantation: A Prospective Study. Kidney360. 2022 Sep 7;3(11):1924-1933. doi: 10.34067/KID.0004282022. eCollection 2022 Nov 24.
PubMed 36514413
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Elastography of Transplanted Kidney (GREFFE_ELASTO IRM)
- ClinicalTrials.gov ID
- NCT03918161
- Acronym / sponsor ID
- CHUBX 2019/17
- Keywords
- Interstitial fibrosis, Tubular atrophy Renal transplantation, Renal allograft, Magnetic Resonance Imaging, Elastography, non-invasive diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 17 Apr 2019 (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.
: GREFFE_ELASTO IRM will evaluate Magnetic Resonance Elastography (MRE) in renal transplant patients with suspected interstitial fibrosis/tubular atrophy lesions requiring biopsy graft sampling under ultrasound control.
The main objective is to search a correlation between renal graft parenchymal elasticity values obtained in vivo by MRE, and the histological data of renal fibrosis by biopsy sampling, and providing a non-invasive tool capable of detecting and monitoring this development over time, making possible in the future to reduce the number of renal biopsies.
Detailed description
The natural history of interstitial fibrosis/tubular atrophy (IF/TA) is a common mechanism of disease progression of transplanted kidneys. The process has been well studied through protocol biopsies. The early phase is characterized by fibrogenesis and the emergence of tubulo-interstitial damage due to immunologic phenomena; the late phase is characterized by the worsening of parenchymal lesions and the occurrence of glomerular sclerosis leading to graft loss.
Today, non-invasive markers of these pathological changes are missing and the protocol biopsies are still the only reliable tool for the diagnosis of IF/TA.
Elasticity imaging has already been proven in the management of chronic liver diseases with Fibroscan. In the field of renal diseases, several studies have been carried out in ultrasound elastography on renal grafts but the renal elastography is more difficult due to the complexity of the kidney (deep organ, two compartments, high vascularity). All these parameters have an influence on the elasticity measures.
The elastography imaging is also performed in MRI (Magnetic resonance imaging): The Magnetic Resonance Elastography (MRE). MRE is less subject to variations in depth, to the experience of the operator and to allow an overall evaluation of the graft.
The potentially eligible patients will be recruited by the nephrologist during a consultation in which renal biopsy is scheduled (as part of current practice). Patients meeting the inclusion criteria and having no exclusion criteria will be offered to participate in this study. If accepted, the only examination specific to this research, the MRE, will be scheduled to be performed the same day as the renal biopsy.
This MRE is painless, non-irradiating, and does not require the injection of contrast medium.
The participation of the patient ends when he leaves the hospital after the biopsy procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will realize Magnetic Resonance Elastography exam
| Arm | Type | Receives |
|---|---|---|
| MRE exam | Experimental | Device: MRE examMagnetic Resonance Elastography (MRE) exam associated with standard T1-weighted and T2-weighted sequences |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18yrs;
- Transplanted kidney patient with suspicion of IF/TA lesions requiring biopsy graft sampling under ultrasound control;
- Signed informed consent;
- Affiliated or beneficiary of health insurance
Key exclusion criteria (4 listed)
- Patients with dilated pyelocaliceal cavities on ultrasound or significant renal artery stenosis (> 80%) on Doppler;
- Pregnant or nursing women;
- Contraindications to MRI;
- Person deprived of liberty, major who is the subject of a legal protection measure or unable to express consent
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 |
|---|---|---|
| MRE examMagnetic Resonance Elastography | Device | MRE exam |
Primary outcome
Mean value of renal elasticity
Time frame: Baseline (defined as during MRE exam)
5 times' measures in comparison with the upper pole of the graft which corresponds to the biopsy site (unit kilo-Pascal)
1 secondary outcome
Average value of renal elasticity
Time frame: Baseline (defined as during MRE exam)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 36514413Chauveau B, Merville P, Soulabaille B, Taton B, Kaminski H, Visentin J, Vermorel A, Bouzgarrou M, Couzi L, Grenier N. Magnetic Resonance Elastography as Surrogate Marker of Interstitial Fibrosis in Kidney Transplantation: A Prospective Study. Kidney360. 2022 Sep 7;3(11):1924-1933. doi: 10.34067/KID.0004282022. eCollection 2022 Nov 24.
- Individual participant dataSharing planned: No
Related trials for Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN)
Enrolling by invitationPhase 2
Belumosudil for Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
Rejection Chronic Renal
Enrolling by invitationPhase 2
Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
Interstitial Fibrosis, Kidney Transplant; Complications
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRE exam in people with Interstitial Fibrosis/Tubular Atrophy of Transplanted Kidneys, run by University Hospital, Bordeaux 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean value of renal elasticity (time frame: Baseline (defined as during MRE exam)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03918161, which also lists 1 linked publication.
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 1 Jun 2026.