Patients waiting for first corpse kidney transplantation or re-transplantation, with PRA values > 50% MedDRA version: 9.1 Level: LLT Classification code 10023439 Term: Kidney transplant rejection
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients of 18-70 years old; Patients in emodialysis suitable for kidney transplantation; patients with PRA > 50%; absence of active infections and procalcitonine in the normality ranges; absence of neoplastic processes; absence of active heart diseases; signed informed consent. 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: Absence of one of the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prevent acute rejection in subjects waiting for first corpse kidney transplantation or re-transplantation.;Secondary Objective: Monitor of patients with signs of rejection.;Primary end point(s): Stabilize the PRA (Panel Reactive Antibodies)value below 10% | — |
Countries
Italy