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

NCT ID: NCT05511779

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2023-04-13

Brief Summary

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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.

Detailed Description

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Conditions

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BK Virus Infection Nephropathy Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Brincidofovir

Intervention Type DRUG

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

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).

Group Type EXPERIMENTAL

Brincidofovir

Intervention Type DRUG

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

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).

Group Type EXPERIMENTAL

Brincidofovir

Intervention Type DRUG

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

Interventions

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Brincidofovir

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

Intervention Type DRUG

Other Intervention Names

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SyB V-1901 BCV

Eligibility Criteria

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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 \[adefovir or tenofovir\])
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SymBio Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 39382091 (View on PubMed)

Other Identifiers

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BCV-BN01

Identifier Type: -

Identifier Source: org_study_id