Phase II, Open-label, Randomized, Multiple Ascending Dose Confirmation of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation - BASTIO

Hoshino Yuji0 个研究点目标入组 36 人开始时间: 2022年8月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Male or female, at least 18 years of age at the time of signing the informed consent at screening.
•2. Kidney transplant recipient.
•3. BK viral load increase and >= 3.6 log IU/mL at 2 weeks post immunosuppression reduction or BK viral load does not decrease by >= 0.3 log IU/mL at 4 weeks post immunosuppression reduction during prescreening.
•(Note: Immunosuppressant reduction needs to be continued during the screening period).
•4. eGFR >= 30 mL/min.
•5. Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/or corticosteroid.

•1. Subjects who weigh >= 120 kg.
•2. National Institutes of Health/NCI CTCAE Grade 2 or higher diarrhea (ie, increase of >= 4 stools per day over usual pretransplant stool output) within 7 days before Day 1.
•3. Poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, =< 5 ug/kg/min) dopamine for renal perfusion within 7 days before Day 1.
•4. Use of renal replacement therapy within 7 days before Day 1.
•5. History of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives [adefovir or tenofovir]).

发起方

Hoshino Yuji