Renal transplant MedDRA version: 13.1 Level: LLT Classification code 10023438 Term: Kidney transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: SONOVUE*1FL 8MCG+1SIR 5ML+ADAT
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Sulfur hexafluoride
CAS Number: 2551-62-4
Concentration unit: µl/ml
Sponsors
IST. DI RICERCHE FARMACOLOG. M. NEGRI
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify the patterns of kidney graft perfusion that are associated with key patterns of renal involvement that may be detected in patients with acute allograft dysfunction. For the purposes of the present analysis, the patterns of kidney involvement will be categorized as follows: 1.Predominant pre-glomerular involvement with: a. Complete or partial occlusion of pre-glomerular arteries and arterioles (vascular allograft rejection) b. Functional (and reversible) vasoconstriction of pre-glomerular arteries and arterioles (acute Cyclosporin or Tacrolimus nephrotoxicity) 2. Predominant post-glomerular involvement with: a. Interstitial edema and cellular infiltration with tubulitis (acute cellular rejection) b. Interstitial edema with tubular cell necrosis (acute tubular necrosis);Secondary Objective: a.To evaluate changes in CE-US parameters recorded throughout the episodes of acute allograft deterioration versus background CE-US parameters recorded at pre-specified time points after kidney transplantation b.To evaluate the relationships between CE-US parameters recorded at pre-specified time points after kidney transplantation and concomitant markers of kidney function as well as baseline histologic changes assessed in pre-implantation kidney biopsies;Primary end point(s): To identify the patterns of kidney graft perfusion that are associated with key patterns of renal involvement that may be detected in patients with acute allograft dysfunction. | — |
Countries
Italy
Outcome results
None listed