Actively Recruiting
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
Led by GlaxoSmithKline · Updated on 2025-10-15
32
Participants Needed
1
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, inclusive
- Body weight greater than or equal to 50 kilograms and body mass index (BMI) between 19 and 40 kg/m2
- Males and females may participate; females must not be pregnant or breastfeeding, must be of non-childbearing potential, or agree to use effective contraception
- Able to give signed informed consent
- For renal impairment groups: severe renal impairment (eGFR < 30 ml/min) or moderate renal impairment (eGFR 30 to 59 ml/min), from any cause except vasculitis or glomerulonephritis
- For healthy controls: healthy based on medical evaluation and normal renal function (eGFR ≥ 90 ml/min)
You will not qualify if you...
- Any medical condition affecting drug absorption, metabolism, or elimination, or increasing study risk or data interpretation issues
- History of vasculitis or any glomerulonephritis
- Use of creatine-containing supplements within 30 days before screening or during the study
- Participation in another interventional study within a timeframe related to the previous investigational product's half-life or biological effect
- Received any oligonucleotide or siRNA treatment within 12 months
- Exposure to more than 4 investigational products in the past 12 months
- Positive blood test for hepatitis B, hepatitis C, or HIV
- Weekly alcohol intake over 14 drinks for males or over 7 drinks for females
- Current or past substance misuse or dependence that might affect participation
- For renal impairment groups: history of renal transplant, anticipated transplant during study, on or likely to require dialysis, positive drug or alcohol screen (unless prescribed medication)
- For healthy controls: positive drug or alcohol screen, urine albumin-to-creatinine ratio over 0.3 mg/mg (300 mg/g)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
GSK Investigational Site
Tampa, Florida, United States, 33603
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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