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

Primary Purpose

BK Virus Infection, Nephropathy, Kidney Transplantation

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Brincidofovir
Sponsored by
SymBio Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BK Virus Infection focused on measuring BK Virus, Nephropathy, Kidney transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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])

Sites / Locations

  • Royal Adelaide HospitalRecruiting
  • Austin HealthRecruiting
  • The Royal Melbourne Hospital
  • Tokyo Medical University Hachioji Medical Center
  • Japanese Red Cross Aichi Medical Center Nagoya Daini HospitalRecruiting
  • Osaka General Medical CenterRecruiting
  • Osaka Metropolitan University Hospital
  • Hokkaido University HospitalRecruiting
  • Sapporo City General Hospital
  • Jichi Medical University Hospital
  • Tokyo Women's Medical University Hospital
  • Osaka University Hospital
  • Fujita Health University HospitalRecruiting
  • Yokohama City University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

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

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2022
Last Updated
February 26, 2023
Sponsor
SymBio Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05511779
Brief Title
Study to Confirm of the Safety and Tolerability of Brincidofovir in Subjects With BK Virus Infection (Viremia) After Kidney Transplantation
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2022 (Actual)
Primary Completion Date
December 16, 2024 (Anticipated)
Study Completion Date
February 16, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SymBio Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Virus Infection, Nephropathy, Kidney Transplantation
Keywords
BK Virus, Nephropathy, Kidney transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Phase: Cohort 1: BCV 0.3 mg/kg BIW
Arm Type
Experimental
Arm Description
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).
Arm Title
Dose Escalation Phase: Cohort 2: BCV 0.4 mg/kg BIW
Arm Type
Experimental
Arm Description
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).
Arm Title
Expansion Phase: BCV Recommended dosage regimen in the Dose Escalation Phase
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Brincidofovir
Other Intervention Name(s)
SyB V-1901, BCV
Intervention Description
BCV 0.3 mg/kg BIW or 0.4 mg/kg BIW administered as a continuous IV infusion over 2 hours
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
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)
Time Frame
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))
Title
Antiviral Effects
Description
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.
Time Frame
From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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])
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuji Hoshino
Phone
+81-3-6684-6616
Email
MedInfo@symbiopharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Yanavich
Organizational Affiliation
SymBio Pharmaceuticals Limited
Official's Role
Study Director
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
Country
Australia
Individual Site Status
Recruiting
Facility Name
Austin Health
City
Melbourne
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Royal Melbourne Hospital
City
Melbourne
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Medical University Hachioji Medical Center
City
Hachiōji
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Nagoya
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka General Medical Center
City
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Hokkaido University Hospital
City
Sapporo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sapporo City General Hospital
City
Sapporo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Tokyo Women's Medical University Hospital
City
Shinjuku-ku
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Osaka University Hospital
City
Suita
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Fujita Health University Hospital
City
Toyoake
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yokohama City University Medical Center
City
Yokohama
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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