Kidney Disease and Ultrasound Imaging

NCT02201537 | Completed

• 1 other identifier: 2012-A01070-43
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief 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 moderated fibrosis at 3 months in our feasibility study.

Conditions

Recipient of Kidney Transplant

Keywords

Ultrasound functional imaging; Chronic kidney Nephropathy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  12 months

Secondary Outcomes (3)

• renal Elastography

  3 months

• Correlation between renal elastography and perfusion and degree of fibrosis and renal function

  12 months

• renal Elastography in patients with chronic kidney disease

  12 months

Study Arms (1)

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.

Device: renal echography

Interventions

renal echography DEVICE

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

Imag-NCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Fondation de l'Avenir: collaborator
• Bracco Imaging S.p.A.: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

NECKER Hospital

Paris, 75015, France

Location

Study Officials

• Jean-Michel CORREAS, PUPH

  Necker Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 28, 2014
• Study Start: March 19, 2013
• Primary Completion: March 19, 2016
• Study Completion: March 19, 2016
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)