Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01815320
Eligibility 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)
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01815320
Study Brief:
Protocol Section:
NCT01815320