CompletedNot Applicable

Kidney Disease and Ultrasound Imaging

France141 participantsStarted 2013-03-19

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

renal Elastography

Timeframe: 3 months

Renal Elastography and contrast-enhanced US

Timeframe: 12 months

Trial details

NCT IDNCT02201537

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03-19

View on ClinicalTrials.gov More Recipient of Kidney Transplant trials