Renal TransplantGREFENCT01234363
Renal Allograft : Evaluation of Parenchymal Fibrosis by Elastography
A study testing Magnetic Resonance Elastography, and Supersonic Shear Imaging in people with Renal Transplant, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant
- What is being tested?
- Magnetic Resonance Elastography, and Supersonic Shear Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Sep 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
- Renal allograft performed less than 3 months before enrolment
Who cannot join
- Contra-indication to magnetic resonance imaging
- Contra-indication to biopsy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot
Lyon, Lyon, 69437
ROUVIERE Olivier, Pr, 4 72 11 09 51 ext. +33, olivier.rouviere@netcourrier.com
ROUVIERE Olivier, Pr
About this study
Official title: Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant
The purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.
- Conditions
- Renal Transplant
- Being tested
- Magnetic Resonance Elastography, and Supersonic Shear Imaging
- Keywords
- Renal allograft, kidney, fibrosis, elastography, elasticity
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Elastography, and Supersonic Shear ImagingDevice
Magnetic Resonance Elastography, and Supersonic Shear Imaging
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Resonance Elastography, Supersonic Shear Imaging | Experimental | Magnetic Resonance Elastography and Supersonic Shear Imaging Receives: Device: Magnetic Resonance Elastography, and Supersonic Shear Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance
Measured: 3 months and 12 months after graft
Secondary outcomes (4)
Number of technical failures
Measured: 12 months
Tolerance (assessed by a questionnaire)
Measured: 3 months and 12 months after graft
Evolution of the elasticity of the transplant between 3 and 12 months after graft
Measured: 3 months and 12 months after graft
Correlation between elasticity and arterial resistance index
Measured: 3 months and 12 months after graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMay 2010
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TransplantStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROUVIERE Olivier, Pr, Principal investigator, Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234363
- Sponsor's protocol ID
- 2009.590
- Acronym
- GREFE
- Status last verified
- Sep 2013
- First submitted
- 26 Jul 2010
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Potential of Elastography for Noninvasive Assessment of Fibrosis in Kidney Transplant
- ClinicalTrials.gov ID
- NCT01234363
- Acronym / sponsor ID
- GREFE / 2009.590
- Conditions
- Renal Transplant
- Keywords
- Renal allograft, kidney, fibrosis, elastography, elasticity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 4 Nov 2010 (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 purpose of this study is to assess the potential of elastography for noninvasive assessment of fibrosis in renal allograft.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnetic Resonance Elastography, Supersonic Shear Imaging | Experimental | Device: Magnetic Resonance Elastography, and Supersonic Shear ImagingMagnetic Resonance Elastography and Supersonic Shear Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Renal allograft performed less than 3 months before enrolment
Key exclusion criteria (2 listed)
- Contra-indication to magnetic resonance imaging
- Contra-indication to biopsy
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 |
|---|---|---|
| Magnetic Resonance Elastography, and Supersonic Shear ImagingMagnetic Resonance Elastography, and Supersonic Shear Imaging | Device | Magnetic Resonance Elastography, Supersonic Shear Imaging |
Primary outcome
Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance
Time frame: 3 months and 12 months after graft
4 secondary outcomes
Number of technical failures
Time frame: 12 months
Tolerance (assessed by a questionnaire)
Time frame: 3 months and 12 months after graft
Evolution of the elasticity of the transplant between 3 and 12 months after graft
Time frame: 3 months and 12 months after graft
Correlation between elasticity and arterial resistance index
Time frame: 3 months and 12 months after graft
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
Related trials for Renal Transplant
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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.
ROUVIERE Olivier, Pr principal investigator
Hospices Civils de Lyon Service de Radiologie, Pavillon P Radio, Hôpital Edouard Herriot, 69437 Lyon Cedex 03
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Elastography, and Supersonic Shear Imaging in people with Renal Transplant, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 19 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ROUVIERE Olivier, Pr (472 11 09 51 ext. +33, olivier.rouviere@netcourrier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between elasticity (as measured by elastography) and (a) Banff score for fibrosis, (b) glomerular filtration rate assessed by creatinine clearance, (c) glomerular filtration rate assessed by insulin clearance (time frame: 3 months and 12 months after graft). 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 19 Sep 2013.