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NCT Number: NCT06960824

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

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).

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Key information

Conditions

Chronic Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Life-Cycle Pharma Tacrolimus

Drug

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).

Kidney transplantation

Procedure

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

Primary outcomes

  1. Incidence of Biopsy Proven Acute Rejection

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe GATAULT, MD

CONTACT

[email protected]

247366392 ext. +33

Yoni ATHEA, Dr.

CONTACT

[email protected]

147684930 ext. +33

Sponsors and collaborators

Lead sponsor

Chiesi SAS

Industry

Registry information

Official study 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

Acronym: NOVOSTART

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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