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

Not yet recruiting

• Conditions: Chronic Renal Disease
• Interventions: Drug: Life-Cycle Pharma Tacrolimus; Procedure: Kidney transplantation

• Registration Number: NCT06960824
• Lead Sponsor: Chiesi SAS

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Last Update Submitted: 2025-04-29
• Study Start: 2025-05
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• 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.
• Patients are either affiliated with or beneficiaries of a social security scheme.

Exclusion Criteria

• 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).
• Previous bariatric (or bypass) surgery.
• Gastrointestinal problems are likely to affect the absorption of the Life-Cycle Pharma Tacrolimus (Envarsus®).
• Diagnosis of Parkinson's disease or any other neurological syndrome causing tremor.
• Patients who are part of another clinical trial or in a period of exclusion from another clinical trial with a molecule under study.
• Pregnant women or breastfeeding.
• Patients under legal protection (guardianship, curatorship) or deprived of their liberty through judicial or administrative decisions.
• Patients under State Medical Assistance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort of patients treated	Life-Cycle Pharma Tacrolimus	Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
Cohort of patients treated	Kidney transplantation	Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
Reference cohort for transplants	Kidney transplantation	Cohorts Transplant reference: two control groups (Tacrolimus twice daily (IR-Tac) and Tacrolimus once daily (ER-Tac)) to determine the main secondary objective.

Primary Outcome Measures

Name	Time	Method
Incidence of Biopsy Proven Acute Rejection	12 months	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.

Trial Locations

Locations (1)

Chru Tours; 🇫🇷 Tours, France