Real-time contrast-enhanced sonography of renal transplant recipients accurately predicts vascular allograft nephropathy

Conditions: Vascular allograft nephropathy represents the main cause of renal allograft loss after 1 yr of transplantation. The trial shall find a way for early diagnostics.

Registration Number: EUCTR2006-001935-23-DE

Lead Sponsor: niversity of Heidelberg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

Patients who have had stable renal allograft function for at least three months.
Patients with a written informed consent.
Patients over 18 years.
Patients of the Department of Nephrology; University Heidelberg (D).

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

Allograft recipients with lymphocele (>100ml),
Patients with significant renal transplant artery stenosis (>70%)
Patients with hydronephrosis of grade 2 (dilatation of the renal pelvis and the calyces, with or without a dilatation of the proximal ureter) or more.
Patients with a familiar incompatibility against SonoVue TM
Patients with pregnancy.
Patients are allergic to proteins.
Patients with pulmonary hypertension.
Patients wirh a thrombotic diathesm

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Real-time contrast enhanced sonography can assess microvascular tissue perfusion using gas-filled microbubbles. The study shall evaluate the feasibility of RT-CES in detecting vascular allograft nephropathy in comparison to colour Doppler ultrasonography.;Secondary Objective: ;Primary end point(s): to evaluate the feasibility of RT-CES in detecting vascular allograft nephropathy in comparison to colour Doppler ultrasonography

Secondary Outcome Measures