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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05511779
Registration number
NCT05511779
Ethics application status
Date submitted
16/08/2022
Date registered
23/08/2022
Titles & IDs
Public title
Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation
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Scientific 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)
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Secondary ID [1]
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BCV-BN01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
BK Virus Infection
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Nephropathy
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Kidney Transplantation
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Brincidofovir
Experimental: Dose Escalation Phase: Cohort 1: BCV 0.3 mg/kg BIW - 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).
Experimental: Dose Escalation Phase: Cohort 2: BCV 0.4 mg/kg BIW - 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).
Experimental: Expansion Phase: BCV Recommended dosage regimen in the Dose Escalation Phase - 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).
Treatment: Drugs: Brincidofovir
BCV 0.3 mg/kg BIW or 0.4 mg/kg BIW administered as a continuous IV infusion over 2 hours
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of treatment-emergent adverse events (TEAEs)
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Assessment method [1]
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* 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)
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Timepoint [1]
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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))
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Primary outcome [2]
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Antiviral Effects
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Assessment method [2]
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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.
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Timepoint [2]
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From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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])
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/02/2025
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Austin Health - Melbourne
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Recruitment hospital [3]
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The Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Japan
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State/province [1]
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Hachioji
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Country [2]
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Japan
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State/province [2]
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Nagoya
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Country [3]
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Japan
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State/province [3]
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Osaka
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Country [4]
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Japan
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State/province [4]
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Sapporo
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Country [5]
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Japan
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State/province [5]
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Shimotsuke
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Country [6]
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Japan
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State/province [6]
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Shinjuku-ku
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Country [7]
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Japan
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State/province [7]
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Suita
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Country [8]
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Japan
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State/province [8]
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Toyoake
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Country [9]
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Japan
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State/province [9]
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Yokohama
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
SymBio Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05511779
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carolyn Yanavich
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Address
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SymBio Pharmaceuticals Limited
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Yuji Hoshino
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Address
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Country
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Phone
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+81-3-6684-6616
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05511779