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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005471-15-DE
Enrollment
30
Registered
2006-09-01
Start date
2006-03-27
Completion date
Unknown
Last updated
2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Pharmaceutical Form: INN or Proposed INN: Perlflutren Concentration type: equal

Sponsors

University of Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026