VIR-2218 for Kidney Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test how the experimental drug VIR-2218 affects people with varying levels of kidney function. It will assess the drug's safety and how the body processes it in individuals with normal kidney function and those with moderate or severe kidney issues. The trial seeks participants who have stable kidney conditions but are otherwise healthy. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
If you are a healthy participant, you must stop taking any prescription or over-the-counter medications (except vitamins and hormonal contraceptives) 30 days before the study. If you have renal impairment, you must be on a stable dose of your current medications for at least 2 weeks before starting the study.
Is there any evidence suggesting that VIR-2218 is likely to be safe for humans?
Research shows that VIR-2218 has been tested for safety in people with varying levels of kidney health. In earlier studies, VIR-2218 showed promise in fighting hepatitis B. The treatment is currently undergoing an early phase clinical trial, focusing primarily on safety. Researchers are closely monitoring for any negative effects or side effects.
Since this is an early trial, detailed safety information might not be fully available yet. However, testing VIR-2218 in people with various kidney conditions suggests that researchers consider it potentially safe for these groups. It's important to remember that while early trials provide some safety information, they are just one step in understanding how well the treatment is tolerated.12345Why do researchers think this study treatment might be promising?
VIR-2218 is unique because it uses RNA interference (RNAi) technology to target and silence specific genes involved in kidney impairment. Unlike the standard treatments for kidney problems, which often focus on managing symptoms like high blood pressure or reducing protein in the urine, VIR-2218 aims to address the condition at a genetic level. Researchers are excited about this approach because it could offer a more direct and potentially more effective way to treat kidney impairment, potentially slowing or even reversing the disease's progression.
What evidence suggests that VIR-2218 might be an effective treatment for kidney impairment?
Research shows that VIR-2218 may help fight the hepatitis B virus by targeting the virus's genetic material, potentially stopping its spread. Although current studies focus on liver conditions, its mechanism suggests broader applications. In this trial, participants with kidney problems will receive VIR-2218 to assess how well the body tolerates and processes the drug. The study aims to determine if VIR-2218 remains safe and effective when kidney function is impaired, which is crucial for understanding its potential in patients with kidney issues.12356
Are You a Good Fit for This Trial?
This trial is for adults who are in good health or have stable moderate to severe kidney impairment, with specific eGFR levels. They must not have uncontrolled hypertension, diabetes, significant heart issues, active infections including HIV and hepatitis viruses, cancer, or a history of organ transplants. Participants should not be on certain medications before the study and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of VIR-2218 to evaluate pharmacokinetics and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VIR-2218
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vir Biotechnology, Inc.
Lead Sponsor