Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation
BK Virus Infection, Nephropathy, Kidney Transplantation
About this trial
This is an interventional treatment trial for BK Virus Infection focused on measuring BK Virus, Nephropathy, Kidney transplantation
Eligibility Criteria
Inclusion Criteria:
- Male or female, at least 18 years of age at the time of signing the informed consent at screening.
- Kidney transplant recipient. "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).
- eGFR ≥ 30 mL/min.
- Subjects under immunosuppression with tacrolimus, MMF/Myfortic, and/or corticosteroid.
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 1.
- Poor clinical prognosis, including active malignancy or use of vasopressors other than low dose (eg, ≤ 5 μg/kg/min) dopamine for renal perfusion within 7 days before Day 1.
- Use of renal replacement therapy within 7 days before Day 1.
- History of intolerance to cidofovir or related compounds (ie, other nucleotide derivatives [adefovir or tenofovir])
Sites / Locations
- Royal Adelaide HospitalRecruiting
- Austin HealthRecruiting
- The Royal Melbourne Hospital
- Tokyo Medical University Hachioji Medical Center
- Japanese Red Cross Aichi Medical Center Nagoya Daini HospitalRecruiting
- Osaka General Medical CenterRecruiting
- Osaka Metropolitan University Hospital
- Hokkaido University HospitalRecruiting
- Sapporo City General Hospital
- Jichi Medical University Hospital
- Tokyo Women's Medical University Hospital
- Osaka University Hospital
- Fujita Health University HospitalRecruiting
- Yokohama City University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Dose Escalation Phase: Cohort 1: BCV 0.3 mg/kg BIW
Dose Escalation Phase: Cohort 2: BCV 0.4 mg/kg BIW
Expansion Phase: BCV Recommended dosage regimen in the Dose Escalation Phase
BCV: 0.3 mg/kg administered as a continuous IV infusion over 2 hours on Day1 and Day4 for 8 weeks (up to a maximum of 14 weeks).
BCV: 0.4 mg/kg administered as a continuous IV infusion over 2 hours on Day1 and Day4 for 8 weeks (up to a maximum of 14 weeks).
BCV: Recommended dosage administered as a continuous IV infusion over 2 hours on Day1 and Day4 for 8 weeks (up to a maximum of 14 weeks).