Bepirovirsen for Kidney Disease
(B-Kind Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called bepirovirsen, an experimental drug, to understand its behavior in the body, particularly in people with kidney disease. Researchers aim to determine how much of the drug enters the bloodstream and how long it remains, comparing results between those with kidney disease and those without. Participants may have severe or moderate kidney disease or be healthy with normal kidney function. Individuals with kidney disease not caused by vasculitis or glomerulonephritis (kidney inflammation) might be suitable candidates. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that bepirovirsen is likely to be safe for humans?
Research has shown that bepirovirsen is generally safe for humans. In studies, most participants tolerated it well, and no major safety issues emerged. The drug's movement through the body resembles that of other treatments, indicating readiness for further testing. Although this trial focuses on kidney disease, researchers are also evaluating bepirovirsen's safety in other conditions.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for kidney disease, which often include medications like ACE inhibitors or ARBs to manage symptoms, Bepirovirsen is unique because it targets the underlying causes of the disease at a molecular level. Researchers are excited about Bepirovirsen because it works by modulating gene expression, which could potentially address the root cause of kidney damage rather than just alleviating symptoms. This novel approach could lead to more effective and longer-lasting treatments, offering hope for patients with severe and moderate renal impairment.
What evidence suggests that bepirovirsen might be an effective treatment for kidney disease?
Research has shown that bepirovirsen holds promise, particularly for treating long-term illnesses. In a previous study on hepatitis B, 28-29% of participants had no detectable virus levels after using bepirovirsen, indicating its potential to significantly reduce the virus in the body. Although primarily tested for liver-related issues, these studies found no serious kidney or liver problems. This trial explores bepirovirsen in various groups, including those with severe and moderate renal impairment, as well as healthy control participants, to understand its effects on kidney disease.15678
Who Is on the Research Team?
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 with severe or moderate kidney disease, not caused by vasculitis or glomerulonephritis. Healthy adults can also join if they weigh at least 50 kg and have a BMI of 19-40 kg/m^2. Women must not be pregnant/breastfeeding and agree to use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of bepirovirsen to evaluate pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bepirovirsen
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School