Transplantation, KidneyIRENNCT00614081
GFR Measurement With Contrast-enhanced Dynamic MRI
A study testing Contrast-enhanced dynamic MRI in people with Transplantation, Kidney and Graft Occlusion, Vascular, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplantation, Kidney, Graft Occlusion, Vascular
- What is being tested?
- Contrast-enhanced dynamic MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a renal transplant presenting with a graft dysfunction or a suspicion of vascular complication (renal artery stenosis…) or of urinary complication (dilatation of excretory system, collection) justifying to perform a non urgent MR examination
- Calculated glomerular clearance (MDRD method) > 20 ml/min
- Age ≥ 18 yo at the time of inclusion
- Negative pregnancy test
- Affiliation to the Social Security
- Written informed consent signed
Who cannot join
- Contra-indication to MRI: neurovascular clips, pacemaker, cochlear implant, orbital metallic object, claustrophobic patients…
- Contra-indication to gadolinium: previous hypersensitivity to Gd-Chelates
- Pregnancy or breastfeeding women
- Adult under legal supervision
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'imagerie Diagnostique et interventionelle de l'adulte, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, 33076
About this study
Official title: Measurement of Glomerular Filtration Rate With Contrast-enhanced Dynamic MR Imaging in Renal Transplant Recipients: Evaluation of the Agreement With the Cr51 -EDTA Method and of Reproducibility
The aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability.
Read the detailed description
Cr51- EDTA method is considered the reference method for measurement of glomerular filtration rate (GFR). However, this method requires several hours and several blood and urinary samplings. Therefore, the ability to get access to this parameter with a simple, valid and reliable method would be a significant progress in clinical follow-up of patients with renal disease. Contrast-enhanced dynamic MRI is now able to give this access to functional parameters as GFR, rapidly and non invasively, becoming an alternative to Cr51-EDTA method. If the acquisition method has been optimized, some problems remain unsolved: is the movement correction worthwhile for the accuracy of the measurement ? Which model provides the most accurate results ? What is the best way to calculate the total GFR (addition of all the voxels or the product of a mean value by the cortical volume)? These questions can be answered only by a comparison with a reference method.
The reference method will be performed after standard hydration, with intravenous injection of 100 µCi of Cr51- EDTA and urinary and blood samplings every 30 minutes during 3h. Dynamic MRI will be performed with fast 3D T1-weighted gradient-echo sequences during 5 minutes after injection of a third of a clinical dose of gadolinium. Post-treatment of images will be done on an off-line program allowing movement correction, conversion of signal intensity into concentration and application of different models. 8 combinations of post-treatment will be tested and compared to the reference method.
- Conditions
- Transplantation, Kidney, Graft Occlusion, Vascular
- Being tested
- Contrast-enhanced dynamic MRI
- Keywords
- Glomerular filtration rate measurement, Contrast-enhanced dynamic MR imaging, Renal transplant recipients
- Medical subject headings
- Graft Occlusion, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced dynamic MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Renal transplant recipients Receives: Device: Contrast-enhanced dynamic MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR according to MRI and Cr51 measurements on the same day
Measured: The same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2013
- Study completionMar 2013
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 Transplantation, KidneyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PEREZ Paul, Dr, Study chair, University Hospital, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614081
- Sponsor's protocol ID
- CHUBX 2005/11
- Acronym
- IREN
- Status last verified
- May 2013
- First submitted
- 22 Nov 2007
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Taton B, De La Faille R, Asselineau J, Perez P, Merville P, Colin T, Combe C, Sourbron S, Grenier N. A prospective comparison of dynamic contrast-enhanced MRI and 51Cr-EDTA clearance for glomerular filtration rate measurement in 42 kidney transplant recipients. Eur J Radiol. 2019 Aug;117:209-215. doi: 10.1016/j.ejrad.2019.02.002. Epub 2019 Feb 4.
PubMed 31221527
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Glomerular Filtration Rate With Contrast-enhanced Dynamic MR Imaging in Renal Transplant Recipients: Evaluation of the Agreement With the Cr51 -EDTA Method and of Reproducibility
- ClinicalTrials.gov ID
- NCT00614081
- Acronym / sponsor ID
- IREN / CHUBX 2005/11
- Conditions
- Transplantation, Kidney, Graft Occlusion, Vascular
- Keywords
- Glomerular filtration rate measurement, Contrast-enhanced dynamic MR imaging, Renal transplant recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Feb 2008 (estimated)
- 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 aim of the study is to optimize and validate this MR-based GFR measurement in patients with a renal transplant, compared with the reference method, the Cr51- EDTA method: to select the most accurate combination of post-treatment of renal MR images and then evaluate its intra- and inter-rater reliability.
Detailed description
Cr51- EDTA method is considered the reference method for measurement of glomerular filtration rate (GFR). However, this method requires several hours and several blood and urinary samplings. Therefore, the ability to get access to this parameter with a simple, valid and reliable method would be a significant progress in clinical follow-up of patients with renal disease. Contrast-enhanced dynamic MRI is now able to give this access to functional parameters as GFR, rapidly and non invasively, becoming an alternative to Cr51-EDTA method. If the acquisition method has been optimized, some problems remain unsolved: is the movement correction worthwhile for the accuracy of the measurement ? Which model provides the most accurate results ? What is the best way to calculate the total GFR (addition of all the voxels or the product of a mean value by the cortical volume)? These questions can be answered only by a comparison with a reference method.
The reference method will be performed after standard hydration, with intravenous injection of 100 µCi of Cr51- EDTA and urinary and blood samplings every 30 minutes during 3h. Dynamic MRI will be performed with fast 3D T1-weighted gradient-echo sequences during 5 minutes after injection of a third of a clinical dose of gadolinium. Post-treatment of images will be done on an off-line program allowing movement correction, conversion of signal intensity into concentration and application of different models. 8 combinations of post-treatment will be tested and compared to the reference method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Contrast-enhanced dynamic MRIRenal transplant recipients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient with a renal transplant presenting with a graft dysfunction or a suspicion of vascular complication (renal artery stenosis…) or of urinary complication (dilatation of excretory system, collection) justifying to perform a non urgent MR examination
- Calculated glomerular clearance (MDRD method) > 20 ml/min
- Age ≥ 18 yo at the time of inclusion
- Negative pregnancy test
- Affiliation to the Social Security
Key exclusion criteria (4 listed)
- Contra-indication to MRI: neurovascular clips, pacemaker, cochlear implant, orbital metallic object, claustrophobic patients…
- Contra-indication to gadolinium: previous hypersensitivity to Gd-Chelates
- Pregnancy or breastfeeding women
- Adult under legal supervision
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 |
|---|---|---|
| Contrast-enhanced dynamic MRI | Device | 1 |
Primary outcome
GFR according to MRI and Cr51 measurements on the same day
Time frame: The same day
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 14 May 2026.
- Results publication: PubMed 31221527Taton B, De La Faille R, Asselineau J, Perez P, Merville P, Colin T, Combe C, Sourbron S, Grenier N. A prospective comparison of dynamic contrast-enhanced MRI and 51Cr-EDTA clearance for glomerular filtration rate measurement in 42 kidney transplant recipients. Eur J Radiol. 2019 Aug;117:209-215. doi: 10.1016/j.ejrad.2019.02.002. Epub 2019 Feb 4.
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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. This study is not recruiting at the moment.
PEREZ Paul, Dr study chair
University Hospital, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast-enhanced dynamic MRI in people with Transplantation, Kidney and Graft Occlusion, Vascular, 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 6 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 14 May 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?
GFR according to MRI and Cr51 measurements on the same day (time frame: The same day). 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 NCT00614081, 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 14 May 2026.