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

Phase 1

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

• Registration Number: EUCTR2005-005471-15-DE
• Lead Sponsor: niversity of Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-01
• Study Completion: 2007-12-31
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients who have had stable renal allograft function for at least three months.
Patients with a vailable allograft biopsy (within the past 3 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 (>50ml),
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 OPTISON TM
Patients with pregnancy.
Patients are allergic to proteins.
Patients with pulmonary hypertension.

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 chronic allograft nephropathy in comparison to colour Doppler ultrasonography.;Secondary Objective: ;Primary end point(s): to evaluate the feasibility of RT-CES in detecting chronic allograft nephropathy in comparison to colour Doppler ultrasonography