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

NCT06960824 | Not Yet Recruiting

• 1 other identifier: 2025-A00256-43
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Renal Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of Biopsy Proven Acute Rejection

  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.

  12 months

Study Arms (2)

Cohort of patients treated

Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.

Drug: Life-Cycle Pharma Tacrolimus; Procedure: Kidney transplantation

Reference cohort for transplants

Cohorts Transplant reference: two control groups (Tacrolimus twice daily (IR-Tac) and Tacrolimus once daily (ER-Tac)) to determine the main secondary objective.

Procedure: Kidney transplantation

Interventions

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).

Cohort of patients treated

Kidney transplantation PROCEDURE

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

Cohort of patients treated; Reference cohort for transplants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Cohort of patients treated with LCPT-based immunosuppression : we will recruit all kidney recipients aged 18 years and older, regardless of gender, who have received Life-Cycle Pharma Tacrolimus (Envarsus®) once daily within 24 hours of transplantation, as judged by the investigator, and who meet the eligibility criteria. 2. Reference transplant cohort : The reference transplant cohort is composed of kidney transplant patients from four French centres (Necker, Saint-Louis, Foch and Toulouse hospitals), comprising 4,000 consecutive patients transplanted between 2005 and 2014.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chiesi SAS: lead

Study Sites (1)

Chru Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Philippe GATAULT, MD

  CHRU TOURS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe GATAULT, MD

CONTACT

247366392; philippe.gatault@univ-tours.fr

Yoni ATHEA, Dr.

CONTACT

147684930; y.athea@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-04

Locations

FR (1)