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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
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)
Secondary ID [1] 0 0
BCV-BN01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BK Virus Infection 0 0
Nephropathy 0 0
Kidney Transplantation 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events (TEAEs)
Timepoint [1] 0 0
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 outcome [2] 0 0
Antiviral Effects
Timepoint [2] 0 0
From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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])

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/02/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Austin Health - Melbourne
Recruitment hospital [3] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Japan
State/province [1] 0 0
Hachioji
Country [2] 0 0
Japan
State/province [2] 0 0
Nagoya
Country [3] 0 0
Japan
State/province [3] 0 0
Osaka
Country [4] 0 0
Japan
State/province [4] 0 0
Sapporo
Country [5] 0 0
Japan
State/province [5] 0 0
Shimotsuke
Country [6] 0 0
Japan
State/province [6] 0 0
Shinjuku-ku
Country [7] 0 0
Japan
State/province [7] 0 0
Suita
Country [8] 0 0
Japan
State/province [8] 0 0
Toyoake
Country [9] 0 0
Japan
State/province [9] 0 0
Yokohama

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SymBio Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carolyn Yanavich
Address 0 0
SymBio Pharmaceuticals Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yuji Hoshino
Address 0 0
Country 0 0
Phone 0 0
+81-3-6684-6616
Fax 0 0
Email 0 0
MedInfo@symbiopharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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