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 Transplantatio

Phase 2

Recruiting

• Conditions: BK virus infection (viremia) after kidney transplantation

• Registration Number: JPRN-jRCT2041220056
• Lead Sponsor: Hoshino Yuji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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.

Exclusion Criteria

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]).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Endpoints:<br>- Incidence of treatment-emergent adverse events (TEAEs), particularly those of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 severity and serious adverse events<br>- Incidence of treatment-related TEAEs<br>- Incidence of adverse events (AEs) requiring permanent discontinuation of BCV<br>- Absolute and changes over time in safety laboratory parameters (ie, hematology, blood chemistry, and urinalysis)<br>Antiviral Effects Endpoints:<br>- Change from baseline in BK viral load in plasma measured through follow-up for each subject<br>- Change from baseline in BK viral load in urine measured through follow-up for each subject <br>- Peak BK viral load in plasma from Week 2 Day 1 through follow-up for each subject <br>- Time-averaged area under the viremia-time curve for BK viral load in plasma from baseline through follow-up for each subject