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

Launched by CHIESI SAS · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called Envarsus® (also known as Life-Cycle Pharma Tacrolimus) for kidney transplant patients. The study aims to see how well this medication works when given right after the kidney transplant, starting on the same day. Researchers will be using advanced technology and tools to monitor the health of participants and check for any signs of rejection of the new kidney.

To be eligible for this study, participants need to be at least 18 years old and must have received a kidney from either a living or deceased donor. They should be willing to take the medication within 24 hours after their transplant and agree to share their health information for the study. However, certain conditions, like previous surgeries or specific health issues, may prevent someone from joining. It's important to note that the study is not yet recruiting participants, so no one can sign up at this moment. Overall, the trial hopes to improve outcomes for kidney transplant patients by carefully studying how this new medication works.

Gender

ALL

Eligibility criteria

• 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.