NCT06960824

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 165 (estimated)
• Sponsor: Chiesi SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

NovoStart is a descriptive study, prospective, multicenter, real-world evidence de-signed to evaluate the clinical efficacy and safety of Once-Daily Extended-Release Tacroli-mus in kidney transplantation using the iBox prognostic system. The NovoStart study will be conducted at 13 academic hospitals in France performing kidney transplants. The study population will comprise three cohorts of patients: * Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective. * Cohorts Transplant reference: two control groups (Twice-Daily Tacrolimus and Once-Daily Tac-rolimus) to determine the main secondary objective.

Conditions

• Chronic Renal Disease

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-05-07
• Last updated: 2025-05-07

Locations

1 site across 1 country: France