Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

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 (BASTION)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511779
• Other study ID #: BCV-BN01
• Status: Recruiting
• Phase: Phase 2
• Start date: October 14, 2022
• Est. completion date: February 16, 2025

Study information

• Verified date: November 2022
• Source: SymBio Pharmaceuticals
• Contact: Yuji Hoshino
• Phone: +81-3-6684-6616
• Email: MedInfo[@]symbiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase II, multicenter, open-label, randomized, standard of care (SOC) controlled, multiple ascending dose study to assess the safety and tolerability of IV Brincidofovir (BCV) in subjects with BKV infection after kidney transplantation. The study will be conducted at multiple study sites in several countries including Australia and Japan. Subjects who meet eligibility criteria will be enrolled in the study and will be randomized and assigned to BCV or SOC (defined as use of the same immunosuppressant administered during prescreening) before receipt of the first dose of study drug in both the Dose Escalation Phase and the Expansion Phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: February 16, 2025
• Est. primary completion date: December 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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])

Related Conditions & MeSH terms

• BK Virus Infection
• Communicable Diseases
• Infections
• Kidney Diseases
• Kidney Transplantation
• Nephropathy
• Viremia
• Virus Diseases

Intervention

Drug:
• Brincidofovir
BCV 0.3 mg/kg BIW or 0.4 mg/kg BIW administered as a continuous IV infusion over 2 hours

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide
Australia	Austin Health	Melbourne
Australia	The Royal Melbourne Hospital	Melbourne
Japan	Tokyo Medical University Hachioji Medical Center	Hachioji
Japan	Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital	Nagoya
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Hokkaido University Hospital	Sapporo
Japan	Sapporo City General Hospital	Sapporo
Japan	Jichi Medical University Hospital	Shimotsuke
Japan	Tokyo Women's Medical University Hospital	Shinjuku-ku
Japan	Osaka University Hospital	Suita
Japan	Fujita Health University Hospital	Toyoake
Japan	Yokohama City University Medical Center	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
SymBio Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	Incidence of TEAEs of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 severity and serious adverse events; Incidence of treatment-related TEAEs; Incidence of adverse events (AEs) requiring permanent discontinuation of BCV; Absolute and changes over time in safety laboratory parameters (ie, hematology, blood chemistry, and urinalysis)	from the time of administration of the first dose of study drug through the follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))
Primary	Antiviral Effects	Change from baseline in BK viral load in plasma measured through follow-up for each subject. Change from baseline in BK viral load in urine measured through follow-up for each subject. Peak BK viral load in plasma from Week 2 Day 1 through follow-up for each subject. Time-averaged area under the viremia-time curve for BK viral load in plasma from baseline through follow-up for each subject.	From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))