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NOT YET RECRUITING
NCT06960824

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

Sponsor: Chiesi SAS

View on ClinicalTrials.gov

Summary

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).

Official title: Real-word Study of the de NOVO Use of Once-daily Extended-release tacrolimuS (LCPT) in Kidney Transplantation Using an ARTificial Intelligence Prognostic System: a Multicenter Prospective Ob-servational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

165

Start Date

2025-05

Completion Date

2027-12-31

Last Updated

2025-05-07

Healthy Volunteers

No

Interventions

DRUG

Life-Cycle Pharma Tacrolimus

Patients 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).

PROCEDURE

Kidney transplantation

Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)

Locations (1)

Chru Tours

Tours, France