Evaluation and promotion of specific adaptative immunity against polyomavirus (BKV) to prevent viral infection after kidney transplantation (BK-VAX project) - BK-VAX

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron0 个研究点目标入组 70 人开始时间: 2023年3月15日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•The patient must be at least 18 years old., The patient must be able to give informed consent in writing, Patient receiving a kidney transplant., The patient must have a maintenance immunosuppressive regimen based on tacrolimus + MMF/MPS + corticosteroids or tacrolimus + rapamycin + corticosteroids., Patient with viral load detectable by PCR in peripheral blood against the BK-virus, Kidney transplant patient at Vall d'Hebron Hospital at most 12 months before viral load detection., Stable renal function with an estimated glomerular filtration rate = 35 ml/min/1.73 m2, Urine protein/creatinine ratio value less than 1 g/g

•Prior diagnosis of T cell-mediated or antibody-mediated rejection., Active cancer excluding non-melanocytic skin cancer, Potentially Fertile Women who do not agree to use measures reliable contraceptives during the trial, who are pregnant, in period of breast-feeding or who present a positive pregnancy test at the time of their inclusion in the study, Patients presenting with another severe systemic infection at the time of randomization., Patients with positive HIV serology

发起方

Fir Huvh Fundacio Institut De Recerca Hospital Universitari Vall De Hebron