Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ART… (NCT06960824) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
France165 participantsStarted 2025-05
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.