B-Kind renal impairment study

12 evidence topics · 2 sources

Objective

Aim stated in the registry record

“This is a 2-part study where all participants will receive bepirovirsen. The study will measure how much bepirovirsen from a single dose gets into the blood, and how long it stays in the blood. The purpose of the study is to understand if blood levels of bepirovirsen are different in adults with kidney disease compared to healthy adults who do not have kidney disease.” (opens the source at this quote in a new tab)

Location and study date

Study dates and status in the registry record

Field	Registry entry
Recruitment status	“Active, not recruiting”
Study start (actual)	“2025-09-26”
Primary completion (actual)	“2026-03-03”
Study completion (estimated)	“2026-08-18”
First posted	“2025-09-11”
Last update posted	“2026-05-22”

Study locations in the registry record

“This study has 3 locations” (opens the source at this quote in a new tab)
“Orlando, Florida, United States, 32809” (opens the source at this quote in a new tab)
“Tampa, Florida, United States, 33603” (opens the source at this quote in a new tab)
“San Antonio, Texas, United States, 78215” (opens the source at this quote in a new tab)

Study design

Phase 1, open-label, single-dose, parallel-group design

“A Phase 1, Open-Label, Single-Dose, Parallel Group, 2-Part Study to Evaluate the Pharmacokinetics of Bepirovirsen in Adult Participants With Severe or Moderate Renal Impairment Compared to Matched Healthy Control Participants” (opens the source at this quote in a new tab)

Design details in the registry record

Field	Registry entry
Allocation	“Non-Randomized”
Interventional model	“Parallel Assignment”
Masking description	“This is an open-label study.”
Phase	“Phase 1”
Other study identifiers	“205872”

Eligibility criteria

Renal function groups

“Severe renal impairment [estimated glomerular filtration rate (eGFR) adjusted for actual body surface area (BSA) less than 30 milliliters per minute (ml/min); Group 1] or moderate renal impairment [eGFR adjusted for actual BSA between 30 and 59 ml/min; Group 2], from any cause other than vasculitis or glomerulonephritis Additional inclusion criteria for healthy control participants with normal renal function (Group 3)” (opens the source at this quote in a new tab)
“Normal renal function (eGFR adjusted for actual BSA greater than or equal to 90 ml/min)” (opens the source at this quote in a new tab)

Other inclusion and exclusion criteria

“Age 18 to 80 years, inclusive” (opens the source at this quote in a new tab)
“Body weight greater than or equal to 50 kilograms (kg) and body mass index (BMI) within the range 19 to 40 kilograms per square meter (kg/m^2).” (opens the source at this quote in a new tab)
“A positive blood test for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).” (opens the source at this quote in a new tab)
“On dialysis or likely to require dialysis during the study.” (opens the source at this quote in a new tab)
“History of renal transplantation or anticipated renal transplant during the study.” (opens the source at this quote in a new tab)

Treatment

Single dose of bepirovirsen in each group

“Participants with severe renal impairment will receive Bepirovirsen.” (opens the source at this quote in a new tab)
“Participants with moderate renal impairment will receive Bepirovirsen.” (opens the source at this quote in a new tab)
“Healthy control participants will receive Bepirovirsen.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using plasma AUC and cmax as the primary endpoints

Registered primary and secondary outcomes

“Plasma Area Under the Concentration Time Curve From Time Zero (Pre-Dose) Extrapolated to Infinite Time [AUC(0-∞)] of Bepirovirsen” (opens the source at this quote in a new tab)
“Maximum Observed Concentration (Cmax) of Bepirovirsen” (opens the source at this quote in a new tab)
“Apparent Clearance (CL/F) of Bepirovirsen” (opens the source at this quote in a new tab)
“Apparent Terminal Phase Half-life (t1/2) of Bepirovirsen” (opens the source at this quote in a new tab)

Renal impairment data gap in the prescribing information

“Insufficient data are available on the safety of HIBSAGO in patients with moderate or severe renal impairment or end stage renal disease (eGFR less than or equal to 59 mL/min/1.73m2).” (opens the prescribing information at this quote)
“Renal Impairment: Bepirovirsen pharmacokinetics were similar between patients with CHB with an eGFR 60 to 89 mL/min/1.73m2 compared to patients with an eGFR ≥90 mL/min/1.73 m2. Insufficient data are available in patients with moderate or severe renal impairment.” (opens the prescribing information at this quote)

Statistical analysis description

Number of participants (Planned and analyzed)

Enrollment in the registry record

Field	Registry entry
Enrollment (actual)	“32”

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

Not applicable.

Safety results

No evidence found.

Study limitations

Summary: study limitations

B-Kind reached primary completion on 2026-03-03 with 32 participants enrolled, but no results are posted on ClinicalTrials.gov and no publication was identified, and the prescribing information states that data are insufficient in moderate or severe renal impairment. The 32 participants are divided among three groups, each participant receives a single dose, and the registry excludes participants with a positive hepatitis B test, dialysis, or renal transplantation.