E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023438 |
E.1.2 | Term | Kidney transplant |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 0 |