Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi SAS

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Life-Cycle Pharma Tacrolimus
  • Kidney transplantation

Treatment groups

165 Participants
are divided into 2 treatment groups

Sponsors and collaborators