Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
NCT ID: NCT06960824
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
165 participants
OBSERVATIONAL
2025-05-31
2027-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort of patients treated
Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
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).
Kidney transplantation
Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)
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.
Kidney transplantation
Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)
Interventions
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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).
Kidney transplantation
Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chiesi SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe GATAULT, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU TOURS
Locations
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Chru Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-A00256-43
Identifier Type: -
Identifier Source: org_study_id
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