NCT06960824Not yet recruiting
Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
Real-word Study of the de NOVO Use of Once-daily Extended-release tacrolimuS (LCPT) in Kidney Transplantation Using an ARTificial Intelligence Prognostic System: a Multicenter Prospective Ob-servational Study
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 165 (estimated)
- First submitted
- 29 Apr 2025
- Start date
- May 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chiesi SAS
- Diseases
- Chronic kidney disease
- NCT number
- NCT06960824
What you commit to
- Study type: Observational
- Planned participants: 165
- From May 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-transplant desensitization.
- Previous bariatric (or bypass) surgery.
Other illness
- Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant).
- Diagnosis of Parkinson's disease or any other neurological syndrome causing tremor.
Other
- Contraindications to the use of Life-Cycle Pharma Tacrolimus (Envarsus®).
- ABO is incompatible with a living donor.
- Gastrointestinal problems are likely to affect the absorption of the Life-Cycle Pharma Tacrolimus (Envarsus®).
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHRU Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.