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

Last updated: December 3, 2024
Sponsor: SymBio Pharmaceuticals
Overall Status: Terminated

Phase

2

Condition

Nephropathy

Kidney Transplantation

Treatment

Brincidofovir

Clinical Study ID

NCT05511779
BCV-BN01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, at least 18 years of age at the time of signing the informed consentat screening.

  • Kidney transplant recipient. "BK viral load increase and ≥ 3.6 log IU/mL" at 2 weekspost immunosuppression reduction or "BK viral load does not decrease by ≥ 0.3 logIU/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/orcorticosteroid.

Exclusion

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

  • Poor clinical prognosis, including active malignancy or use of vasopressors otherthan low dose (eg, ≤ 5 μg/kg/min) dopamine for renal perfusion within 7 days beforeDay 1.

  • Use of renal replacement therapy within 7 days before Day 1.

  • History of intolerance to cidofovir or related compounds (ie, other nucleotidederivatives [adefovir or tenofovir])

Study Design

Total Participants: 1
Treatment Group(s): 1
Primary Treatment: Brincidofovir
Phase: 2
Study Start date:
October 14, 2022
Estimated Completion Date:
April 13, 2023

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide,
    Australia

    Site Not Available

  • Austin Health

    Melbourne,
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital

    Melbourne,
    Australia

    Site Not Available

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji,
    Japan

    Site Not Available

  • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

    Nagoya,
    Japan

    Site Not Available

  • Osaka General Medical Center

    Osaka,
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka,
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Sapporo,
    Japan

    Active - Recruiting

  • Sapporo City General Hospital

    Sapporo,
    Japan

    Site Not Available

  • Jichi Medical University Hospital

    Shimotsuke,
    Japan

    Site Not Available

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku,
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita,
    Japan

    Site Not Available

  • Research Site

    Tokyo,
    Japan

    Site Not Available

  • Fujita Health University Hospital

    Toyoake,
    Japan

    Site Not Available

  • Yokohama City University Medical Center

    Yokohama,
    Japan

    Site Not Available

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

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