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

NCT05511779 | Terminated Phase 2 DMC

• 1 other identifier: BCV-BN01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BK Virus Infection; Nephropathy; Kidney Transplantation

Keywords

BK Virus; Nephropathy; Kidney transplantation

Outcome Measures

Primary Outcomes (2)

• 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))

• 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))

Study Arms (3)

Dose Escalation Phase: Cohort 1: BCV 0.3 mg/kg BIW

EXPERIMENTAL

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).

Drug: Brincidofovir

Dose Escalation Phase: Cohort 2: BCV 0.4 mg/kg BIW

EXPERIMENTAL

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).

Drug: Brincidofovir

Expansion Phase: BCV Recommended dosage regimen in the Dose Escalation Phase

EXPERIMENTAL

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).

Drug: Brincidofovir

Interventions

Brincidofovir DRUG

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

Also known as: SyB V-1901, BCV

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[adefovir or tenofovir\])

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (1)

Research Site

Tokyo, Japan

Location

Related Publications (2)

• Wojciechowski D, Kotton CN. BK Nephropathy in the Modern Era: What Have We Learned? Kidney360. 2025 Dec 1;6(12):2257-2262. doi: 10.34067/KID.0000000967. Epub 2025 Aug 19.

  PMID: 40828617 DERIVED

• Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.

  PMID: 39382091 DERIVED

MeSH Terms

Conditions

Kidney Diseases

Interventions

brincidofovir

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 23, 2022
• Study Start: October 14, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)