Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
NCT06960824 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 165
Last updated 2025-05-07
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).
Conditions
- Chronic Renal Disease
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)
Sponsors & Collaborators
-
Chiesi SAS
lead INDUSTRY
Principal Investigators
-
Philippe GATAULT, MD · CHRU TOURS
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-31
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- France
Study Locations
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