Phase
Condition
Nephropathy
Kidney Transplantation
Treatment
Brincidofovir
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, at least 18 years of age at the time of signing the informed consentat screening.
Kidney transplant recipient. "BK viral load increase and ≥ 3.6 log IU/mL" at 2 weekspost immunosuppression reduction or "BK viral load does not decrease by ≥ 0.3 logIU/mL" at 4 weeks post immunosuppression reduction during prescreening.
(Note: Immunosuppressant reduction needs to be continued during the screening period).
eGFR ≥ 30 mL/min.
Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/orcorticosteroid.
Exclusion
Exclusion Criteria:
Subjects who weigh ≥ 120 kg.
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
Poor clinical prognosis, including active malignancy or use of vasopressors otherthan low dose (eg, ≤ 5 μg/kg/min) dopamine for renal perfusion within 7 days beforeDay 1.
Use of renal replacement therapy within 7 days before Day 1.
History of intolerance to cidofovir or related compounds (ie, other nucleotidederivatives [adefovir or tenofovir])
Study Design
Connect with a study center
Royal Adelaide Hospital
Adelaide,
AustraliaSite Not Available
Austin Health
Melbourne,
AustraliaActive - Recruiting
The Royal Melbourne Hospital
Melbourne,
AustraliaSite Not Available
Tokyo Medical University Hachioji Medical Center
Hachiōji,
JapanSite Not Available
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya,
JapanSite Not Available
Osaka General Medical Center
Osaka,
JapanActive - Recruiting
Osaka Metropolitan University Hospital
Osaka,
JapanSite Not Available
Hokkaido University Hospital
Sapporo,
JapanActive - Recruiting
Sapporo City General Hospital
Sapporo,
JapanSite Not Available
Jichi Medical University Hospital
Shimotsuke,
JapanSite Not Available
Tokyo Women's Medical University Hospital
Shinjuku-ku,
JapanSite Not Available
Osaka University Hospital
Suita,
JapanSite Not Available
Research Site
Tokyo,
JapanSite Not Available
Fujita Health University Hospital
Toyoake,
JapanSite Not Available
Yokohama City University Medical Center
Yokohama,
JapanSite Not Available
Pusan National University Hospital
Busan,
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul,
Korea, Republic ofSite Not Available
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