## Protocol Section
### Identification Module
**NCT ID:** 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)

#### Organization Study ID Info
**ID:** BCV-BN01
#### Organization
**Class:** INDUSTRY
**Full Name:** SymBio Pharmaceuticals
### Status Module
#### Completion Date
**Date:** 2025-02-16

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-16

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-10-14

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2022-08-23
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-16
**Study First Submit QC Date:** 2022-08-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** SymBio Pharmaceuticals

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- BK Virus Infection

- Nephropathy

- Kidney Transplantation

**Keywords:**

- BK Virus

- Nephropathy

- Kidney transplantation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 36

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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).

**Intervention Names:**

- Drug: Brincidofovir

**Label:** Dose Escalation Phase: Cohort 1: BCV 0.3 mg/kg BIW

**Type:** EXPERIMENTAL

#### Arm Group 2

**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).

**Intervention Names:**

- Drug: Brincidofovir

**Label:** Dose Escalation Phase: Cohort 2: BCV 0.4 mg/kg BIW

**Type:** EXPERIMENTAL

#### Arm Group 3

**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 Names:**

- Drug: Brincidofovir

**Label:** Expansion Phase: BCV Recommended dosage regimen in the Dose Escalation Phase

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 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

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

**Name:** Brincidofovir

**Other Names:**

- SyB V-1901

- BCV

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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)

**Measure:** Incidence of treatment-emergent adverse events (TEAEs)

**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))

**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.

**Measure:** Antiviral Effects

**Time Frame:** From baseline to follow-up visit(up to 14 weeks (treatment period) and 30 days (follow-up period))

### Eligibility Module

**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 \[adefovir or tenofovir\])

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** MedInfo@symbiopharma.com

**Name:** Yuji Hoshino

**Phone:** +81-3-6684-6616

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Adelaide

**Country:** Australia

**Facility:** Royal Adelaide Hospital

**Status:** RECRUITING

**Location 2:**

**City:** Melbourne

**Country:** Australia

**Facility:** Austin Health

**Status:** RECRUITING

**Location 3:**

**City:** Melbourne

**Country:** Australia

**Facility:** The Royal Melbourne Hospital

**Status:** NOT_YET_RECRUITING

**Location 4:**

**City:** Hachiōji

**Country:** Japan

**Facility:** Tokyo Medical University Hachioji Medical Center

**Status:** NOT_YET_RECRUITING

**Location 5:**

**City:** Nagoya

**Country:** Japan

**Facility:** Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

**Status:** RECRUITING

**Location 6:**

**City:** Osaka

**Country:** Japan

**Facility:** Osaka General Medical Center

**Status:** RECRUITING

**Location 7:**

**City:** Osaka

**Country:** Japan

**Facility:** Osaka Metropolitan University Hospital

**Status:** NOT_YET_RECRUITING

**Location 8:**

**City:** Sapporo

**Country:** Japan

**Facility:** Hokkaido University Hospital

**Status:** RECRUITING

**Location 9:**

**City:** Sapporo

**Country:** Japan

**Facility:** Sapporo City General Hospital

**Status:** NOT_YET_RECRUITING

**Location 10:**

**City:** Shimotsuke

**Country:** Japan

**Facility:** Jichi Medical University Hospital

**Status:** NOT_YET_RECRUITING

**Location 11:**

**City:** Shinjuku-ku

**Country:** Japan

**Facility:** Tokyo Women's Medical University Hospital

**Status:** NOT_YET_RECRUITING

**Location 12:**

**City:** Suita

**Country:** Japan

**Facility:** Osaka University Hospital

**Status:** NOT_YET_RECRUITING

**Location 13:**

**City:** Toyoake

**Country:** Japan

**Facility:** Fujita Health University Hospital

**Status:** RECRUITING

**Location 14:**

**City:** Yokohama

**Country:** Japan

**Facility:** Yokohama City University Medical Center

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** SymBio Pharmaceuticals Limited

**Name:** Carolyn Yanavich

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000018805

- Term: Sepsis

- ID: D000018746

- Term: Systemic Inflammatory Response Syndrome

- ID: D000007249

- Term: Inflammation

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Nephropathy

- ID: M10283

- Name: Infections

- Relevance: HIGH

- As Found: Infection

- ID: M6368

- Name: Communicable Diseases

- Relevance: HIGH

- As Found: Infection

- ID: M17522

- Name: Virus Diseases

- Relevance: HIGH

- As Found: Virus Infection

- ID: M17511

- Name: Viremia

- Relevance: HIGH

- As Found: Viremia

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20864

- Name: Sepsis

- Relevance: LOW

- As Found: Unknown

- ID: M16869

- Name: Toxemia

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M20818

- Name: Systemic Inflammatory Response Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007239

- Term: Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000014777

- Term: Virus Diseases

- ID: D000014766

- Term: Viremia

- ID: D000007674

- Term: Kidney Diseases

### Intervention Browse Module - Ancestors

- ID: D000000998

- Term: Antiviral Agents

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M351625

- Name: Brincidofovir

- Relevance: HIGH

- As Found: Renal Stones

- ID: M4314

- Name: Antiviral Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000525733

- Term: Brincidofovir

### Misc Info Module

#### Removed Countries

- Country: Korea, Republic of

- Version Holder: 2024-05-24
