Status:
NOT_YET_RECRUITING
Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
Lead Sponsor:
Chiesi SAS
Conditions:
Chronic Renal Disease
Eligibility:
All Genders
18+ years
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-jec...
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 transplantat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT06960824
Start Date
May 1 2025
End Date
December 31 2027
Last Update
May 7 2025
Active Locations (1)
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1
Chru Tours
Tours, France, 37044