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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

— Observational Chronic Renal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Life-Cycle Pharma Tacrolimus, Kidney transplantation.
Who it may be relevant to
Registry conditions: Chronic Renal Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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)

Primary outcome measures

  • Incidence of Biopsy Proven Acute Rejection [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Chru Tours — Tours

Identifiers

NCT: NCT06960824 · 2025-A00256-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗