Recipient of Kidney TransplantImag-NCTNCT02201537
Kidney Disease and Ultrasound Imaging
A study testing renal echography in people with Recipient of Kidney Transplant, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The hypothesis of our study is that a correlation exists between the couple ultrasound elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as elastography alone did not allow to differentiate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recipient of Kidney Transplant
- What is being tested?
- renal echography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2013to 19 Mar 2016
- 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
- Age ≥ 18 years;
- Patient with informed consent;
- Recipient of a living donor graft or cadaveric donor patient;
- No contraindication for biopsy of the graft;
- No contraindication to the injection of SonoVue ®:
- hypersensitivity to sulfur hexafluoride
Show all 9Show fewer
- acute coronary syndrome, unstable ischemic heart disease (myocardial infarction phase formation or evolution, typical resting angina in the previous 7 days, significant worsening of cardiac symptoms in the previous 7 days, recent intervention on the coronary arteries or another factor suggesting clinical instability (eg, recent deterioration of ECG changes in clinical or laboratory parameters), acute heart failure, stage III or IV heart failure, severe arrhythmias.
- right-left shunt, severe pulmonary hypertension (PAP> 90 mmHg), uncontrolled systemic hypertension, respiratory distress syndrome
- Affiliated to a social security scheme
Who cannot join
- Refusal to participate in the study;
- Inability / refusal to give informed consent;
- contraindication for biopsy testing graft;
- Presence of a contraindication to the injection of SonoVue ®.
- Presence of a peripheral venous access in a non-restricted already infused patient, not pickable under ultrasound
- Breastfeeding, pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Diagnosis of Chronic Kidney Disease in Renal Transplants Kidney Transplanted Using Ultrasound Functional Imaging
The hypothesis of our study is that a correlation exists between the couple ultrasound elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as elastography alone did not allow to differentiate moderated fibrosis at 3 months in our feasibility study.
Read the detailed description
Kidney transplant patients are exposed to long-term immunosuppressive therapy, and have an increased risk of infections and cancer, while a lack of treatment increases the risk of rejection. The development of imaging techniques to characterize the status of the graft remains a challenge in transplantation. Ideally, they should identify complications (acute rejection, chronic allograft nephropathy, nephrotoxicity ...) without the need for invasive procedures and thus lead to better customization of immunosuppressive therapy.
The post-transplant follow-up is based on the monitoring of graft function. Impaired function suggests the possibility of a complication, but requires confirmation by an invasive procedure such as renal biopsy. In addition, the diagnosis remains complex at a relatively advanced stage of the process due to damage to the graft parenchyma. To anticipate the altered function and detect subclinical lesions, screening biopsies have been used to diagnose chronic rejection. By definition, screening for subclinical lesions can not be based on any biological parameter; the diagnosis of subclinical complications thus requires performing multiple systematic biopsies, which are scheduled at 3 months and 1 year.
Doppler ultrasound is an imaging method of choice for the study of renal transplant, but it cannot diagnose the NCT due to the absence of specific findings. The lack of early diagnostic test for NCT is a major obstacle to the development and evaluation of new therapeutic options to prevent, slow or stabilize renal fibrosis. It is therefore necessary to develop a non-invasive imaging technique for the early diagnosis of NCT.
Ultrasound elastography is a technique that allows tissue stiffness measurements and provides a parametric picture.
The main objective of our study is to evaluate the performances of elastography and measurement of renal perfusion (area under the ROC curve) to diagnose the NCT and determine for each both measures a threshold to maximize the sensitivity. These performances will be evaluated at 3 months and 12 months. The results can also be compared to other imaging modalities such as functional MRI, and to clinical events (obstruction, infection…).
Functional ultrasound imaging should identify diagnostic and prognostic criteria of NCT, and enable the development of less invasive therapeutic protocols to evaluate new therapeutic approaches
- Conditions
- Recipient of Kidney Transplant
- Being tested
- renal echography
- Keywords
- Ultrasound functional imaging, Chronic kidney Nephropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal echographyDevice
Renal biopsy will be performed at 3 and 12 months.
The functional imaging examinations will be held as follows:
Step 1: the conventional Doppler ultrasound Step 2: ultrasound elastography Step 3: CEUS
| Study group | Role | What they receive |
|---|---|---|
| Imag-NCT | Other | The ultrasound functional imaging will be performed at J15 (before the patient is discharged from service Transplantation) and at 3 and 12 months after the transplant.
The functional imaging examinations will be held as follows:
* 1st stage - the conventional Doppler ultrasound:
* 2nd stage - the elastography:.
* Step 3 - CEUS: It is performed on an ultrasound machine with a specific module with the same probes as conventional ultrasound. It requires the injection of 1.5 ml of SonoVue ®, a contrast ultrasound.
Renal biopsy will be performed after the functional ultrasound at 3 and 12 months. Receives: Device: renal echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal Elastography
The assessment of renal function is performed by the serum creatinine and calculation of glomerular filtration rate estimated by the formula Modified Diet in Renal Disease (MDRD) 4-parameter at 3 and 12 months post-transplantation. In addition, a measure of glomerular filtration rate using the technique to iohexol is performed routinely at 12 months post-transplant as part of routine monitoring of transplant patient.
The ultrasound functional imaging will be performed at 15 days, 3 and 12 months after transplantation.
The functional imaging examinations will be held as follows:
Step 1: the conventional Doppler ultrasound 2nd step: the ultrasound elastography Step 3 : CEUS
Measured: 3 months
Renal Elastography and contrast-enhanced US
The assessment of renal function is performed by the serum creatinine and calculation of glomerular filtration rate estimated by the formula Modified Diet in Renal Disease (MDRD) 4-parameter at 3 and 12 months post-transplantation. In addition, a measure of glomerular filtration rate using the technique to iohexol is performed routinely at 12 months post-transplant as part of routine monitoring of transplant patient.
The ultrasound functional imaging will be performed at 15 days, 3 and 12 months after transplantation.
The functional imaging examinations will be held as follows:
Step 1: the conventional Doppler ultrasound 2nd step: the ultrasound elastography Step 3 : CEUS
Measured: 12 months
Secondary outcomes (3)
renal Elastography
Correlation between elastography and renal function with degree of fibrosis and renal function will be calculate using Pearson coefficient of correlation
Measured: 3 months
Correlation between renal elastography and perfusion and degree of fibrosis and renal function
Correlation between elastography and renal function with degree of fibrosis and renal function will be calculate using Pearson coefficient of correlation
Measured: 12 months
renal Elastography in patients with chronic kidney disease
this two measures will be express in evolution percentage at J15 and 3 months. The evolution percentage will be compared with imaging of patient with chronic kidney disease to determine if elastography and renal perfusion can predict chronic kidney disease at one year.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study start19 Mar 2013
- Primary completion19 Mar 2016
- Study completion19 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recipient of Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir, Bracco Imaging S.p.A., URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Michel CORREAS, PUPH, Principal investigator, Necker Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201537
- Sponsor's protocol ID
- 2012-A01070-43
- Acronym
- Imag-NCT
- Status last verified
- Oct 2025
- First submitted
- 17 Jul 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Diagnosis of Chronic Kidney Disease in Renal Transplants Kidney Transplanted Using Ultrasound Functional Imaging
- ClinicalTrials.gov ID
- NCT02201537
- Acronym / sponsor ID
- Imag-NCT / 2012-A01070-43
- Conditions
- Recipient of Kidney Transplant
- Keywords
- Ultrasound functional imaging, Chronic kidney Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir, Bracco Imaging S.p.A., URC-CIC Paris Descartes Necker Cochin
- Study start
- 19 Mar 2013 (actual)
- Primary completion
- 19 Mar 2016 (actual)
- Study completion
- 19 Mar 2016 (actual)
- First posted
- 28 Jul 2014 (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 hypothesis of our study is that a correlation exists between the couple ultrasound elastography- renal perfusion estimated with contrast-enhanced ultrasound and the degree of fibrosis estimated in a semi-quantitative way in 4 stages (0; 25 %; 25-50 %; > 50 %), as elastography alone did not allow to differentiate moderated fibrosis at 3 months in our feasibility study.
Detailed description
Kidney transplant patients are exposed to long-term immunosuppressive therapy, and have an increased risk of infections and cancer, while a lack of treatment increases the risk of rejection. The development of imaging techniques to characterize the status of the graft remains a challenge in transplantation. Ideally, they should identify complications (acute rejection, chronic allograft nephropathy, nephrotoxicity ...) without the need for invasive procedures and thus lead to better customization of immunosuppressive therapy.
The post-transplant follow-up is based on the monitoring of graft function. Impaired function suggests the possibility of a complication, but requires confirmation by an invasive procedure such as renal biopsy. In addition, the diagnosis remains complex at a relatively advanced stage of the process due to damage to the graft parenchyma. To anticipate the altered function and detect subclinical lesions, screening biopsies have been used to diagnose chronic rejection. By definition, screening for subclinical lesions can not be based on any biological parameter; the diagnosis of subclinical complications thus requires performing multiple systematic biopsies, which are scheduled at 3 months and 1 year.
Doppler ultrasound is an imaging method of choice for the study of renal transplant, but it cannot diagnose the NCT due to the absence of specific findings. The lack of early diagnostic test for NCT is a major obstacle to the development and evaluation of new therapeutic options to prevent, slow or stabilize renal fibrosis. It is therefore necessary to develop a non-invasive imaging technique for the early diagnosis of NCT.
Ultrasound elastography is a technique that allows tissue stiffness measurements and provides a parametric picture.
The main objective of our study is to evaluate the performances of elastography and measurement of renal perfusion (area under the ROC curve) to diagnose the NCT and determine for each both measures a threshold to maximize the sensitivity. These performances will be evaluated at 3 months and 12 months. The results can also be compared to other imaging modalities such as functional MRI, and to clinical events (obstruction, infection…).
Functional ultrasound imaging should identify diagnostic and prognostic criteria of NCT, and enable the development of less invasive therapeutic protocols to evaluate new therapeutic approaches
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imag-NCT | Other | Device: renal echographyThe ultrasound functional imaging will be performed at J15 (before the patient is discharged from service Transplantation) and at 3 and 12 months after the transplant. The functional imaging examinations will be held as follows: * 1st stage - the conventional Doppler ultrasound: * 2nd stage - the elastography:. * Step 3 - CEUS: It is performed on an ultrasound machine with a specific module with the same probes as conventional ultrasound. It requires the injection of 1.5 ml of SonoVue ®, a contrast ultrasound. Renal biopsy will be performed after the functional ultrasound at 3 and 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- Patient with informed consent;
- Recipient of a living donor graft or cadaveric donor patient;
- No contraindication for biopsy of the graft;
- No contraindication to the injection of SonoVue ®:
Key exclusion criteria (6 listed)
- Refusal to participate in the study;
- Inability / refusal to give informed consent;
- contraindication for biopsy testing graft;
- Presence of a contraindication to the injection of SonoVue ®.
- Presence of a peripheral venous access in a non-restricted already infused patient, not pickable under ultrasound
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 |
|---|---|---|
| renal echographyRenal biopsy will be performed at 3 and 12 months. The functional imaging examinations will be held as follows: Step 1: the conventional Doppler ultrasound Step 2: ultrasound elastography Step 3: CEUS | Device | Imag-NCT |
Primary outcome
renal Elastography
Time frame: 3 months
The assessment of renal function is performed by the serum creatinine and calculation of glomerular filtration rate estimated by the formula Modified Diet in Renal Disease (MDRD) 4-parameter at 3 and 12 months post-transplantation. In addition, a measure of glomerular filtration rate using the technique to iohexol is performed routinely at 12 months post-transplant as part of routine monitoring of transplant patient. The ultrasound functional imaging will be performed at 15 days, 3 and 12 months after transplantation. The functional imaging examinations will be held as follows: Step 1: the conventional Doppler ultrasound 2nd step: the ultrasound elastography Step 3 : CEUS
Renal Elastography and contrast-enhanced US
Time frame: 12 months
The assessment of renal function is performed by the serum creatinine and calculation of glomerular filtration rate estimated by the formula Modified Diet in Renal Disease (MDRD) 4-parameter at 3 and 12 months post-transplantation. In addition, a measure of glomerular filtration rate using the technique to iohexol is performed routinely at 12 months post-transplant as part of routine monitoring of transplant patient. The ultrasound functional imaging will be performed at 15 days, 3 and 12 months after transplantation. The functional imaging examinations will be held as follows: Step 1: the conventional Doppler ultrasound 2nd step: the ultrasound elastography Step 3 : CEUS
3 secondary outcomes
renal Elastography
Time frame: 3 months
Correlation between renal elastography and perfusion and degree of fibrosis and renal function
Time frame: 12 months
renal Elastography in patients with chronic kidney disease
Time frame: 12 months
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 20 Nov 2025.
Related trials for Recipient of Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Not yet recruitingPhase 2/3
Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Kidney Transplant Recipient
Not yet recruitingPhase 2
Cemiplimab for Kidney Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
Kidney Transplant Recipient, Cutaneous Squamous Cell Carcinoma (CSCC)
Not yet recruitingPhase 3
Cardiac Improvement by Eplerenone Among Patients Under Cyclosporine or Tacrolimus for Kidney Transplantation.
Kidney Transplantation
Active, not recruitingPhase 1/2
Cell Therapy for Immunomodulation in Kidney Transplantation
Kidney Transplantation
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.
Jean-Michel CORREAS, PUPH principal investigator
Necker Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing renal echography in people with Recipient of Kidney Transplant, run by Assistance Publique - Hôpitaux de Paris 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 9 inclusion and 6 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 20 Nov 2025. 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?
renal Elastography (time frame: 3 months). The study lists 2 primary outcomes in all. 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 20 Nov 2025.