Viral load guided Immunosuppression after Lung Transplantation An open-label, randomized, controlled, parallel-group, multicenter trial(VIGILung)

Philipps-Universität Marburg0 个研究点目标入组 144 人开始时间: 2020年3月4日最近更新: 2020年9月21日

试验速览

暂无简介。

•1.patients 21 to 42 days after de novo lung transplantation (bilateral or combined)
•2.age = 18 years
•3.tacrolimus based immunosuppression
•4.written informed consent
•5.detectable TTV load at randomization (>2,7 log 10)
•6.negative serum pregnancy test in women of childbearing potential.
•7.Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, a combination of hormonal contraceptive (oral, injectable or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 144
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. history or high-risk of obstructive airway complications after lung transplantation
•2.respiratory failure (need for oxygen therapy or ventilation at screening after lung transplantation)
•3.inability to undergo transbronchial biopsy
•4.advanced kidney failure (GFR CKD-EPI <30 ml/min/1.73m2 at inclusion and/or current renal replacement therapy at inclusion or randomization
•5.advanced liver cirrhosis (CHILD-Pugh Score C) after lung transplantation
•6.fluctuating tacrolimus drug levels (less than 20% in target range after transplantation)
•7.patients with symptoms of significant mental illness and with inability to cooperate or communicate with the investigator.
•8.unlikeliness to comply with the study requirements
•9.HIV positivity
•10.evidence of unsolved drug or alcohol addiction
•11.breastfeeding women
•12.simultaneous participation in other clinical trials if not permitted by the steering committee

发起方