The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus \[Life-Cycle Pharma Tacrolimus\] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms).
Kidney recipients aged 18 years and older.
Kidney recipients were transplanted from living or deceased donors
Patients receiving Envarsus® [Life-Cycle Pharma Tacrolimus] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics.
Patients are willing to participate in the study and do not oppose the use of their data.
Contraindications to the use of Life-Cycle Pharma Tacrolimus (Envarsus®).
Pre-transplant desensitization.
ABO is incompatible with a living donor.
Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant).
1. Cohort of patients treated with LCPT-based immunosuppression : we will recruit all kidney recipients aged 18 years and older, regardless of gender, who have received Life-Cycle Pharma Tacrolimus (Envarsus®) once daily within 24 hours of transplantation, as judged by the investigator, and who meet the eligibility criteria. 2. Reference transplant cohort : The reference transplant cohort is composed of kidney transplant patients from four French centres (Necker, Saint-Louis, Foch and Toulouse hospitals), comprising 4,000 consecutive patients transplanted between 2005 and 2014.
Cohort
Prospective
Life-Cycle Pharma Tacrolimus
DrugPatients receiving LCPT Envarsus® \[Life-Cycle Pharma Tacrolimus\] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics (SmPC).
Kidney transplantation
Procedure/SurgeryKidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)
Incidence of Biopsy Proven Acute Rejection
The primary endpoint is the incidence of Biopsy Proven Acute Rejection between the Life-Cycle Pharma Tacrolimus cohort and the control groups of the transplant reference cohort.
This trial is not recruiting at the moment. You can still explore other options:
