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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Chiesi SAS
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Incidence of Biopsy Proven Acute Rejection
研究概览
简要总结
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).
详细描述
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 transplantation using the iBox prognostic system.
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Cohort of patients treated
Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
干预措施: Life-Cycle Pharma Tacrolimus (Drug)
Cohort of patients treated
Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
干预措施: Kidney transplantation (Procedure)
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.
干预措施: Kidney transplantation (Procedure)
结局指标
主要结局
Incidence of Biopsy Proven Acute Rejection
时间窗: 12 months
The primary endpoint is the incidence of Biopsy Proven Acute Rejection between the Life-Cycle Pharma Tacrolimus cohort and the control groups of the transplant reference cohort.
次要结局
未报告次要终点