A PILOT, EXPLORATIVE STUDY TO IDENTIFY CONTRAST-ENHANCED ULTRASOUND (CE-US) PATTERNS THAT CHARACTERIZE ACUTE ALLOGRAFT REJECTION AND OTHER CAUSES OF ACUTE ALLOGRAFT DYSFUNCTION IN RENAL TRANSPLANT RECIPIENTS - CE-US in renal transplantatio

• Conditions: Renal transplant; MedDRA version: 13.1Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2010-019126-13-IT
• Lead Sponsor: IST. DI RICERCHE FARMACOLOG. M. NEGRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-13
• Last Update Posted: 16 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Age > 18 years; Kidney transplantation with a functioning graft (dialysis independence);Clinical indication to histologic evaluation of the kidney graft; Written Informed consent (according to the Declaration of Helsinki guidelines)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Specific contraindications to histologic evaluation of the kidney graft (bleeding time > 15 min, intra-abdominal implantation of the graft) • Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue. • Recent Acute Coronary Syndrome (ACS) or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronar artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders. • Right-to-left shunts, severe pulmonary hypertension (PAP >90 mmHg), uncontrolled systemic hypertension, and adult respiratory distress syndrome.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified