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Virus Therapy
VIR-2218 for Kidney Impairment
Phase 1
Recruiting
Research Sponsored by Vir Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have normal renal function as defined by eGFR ≥ 90 mL/min/1.73m2 based on the Modification of Diet in Renal Disease (MDRD) equation determined from the mean of two measurements of serum creatinine at screening (Additional Criteria Specific to Healthy Participants)
Moderate RI as defined by eGFR level 30-59 mL/min/1.73m2 based on the MDRD equation, or Severe RI as defined by eGFR level 15-29 mL/min/1.73m2 based on the MDRD equation (Additional Criteria Specific to Participants with Renal Impairment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial will look at how kidney function affects the safety, effectiveness and tolerability of a new drug in people with healthy kidneys and those with different levels of kidney disease.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests VIR-2218's effects on people with different levels of kidney function. It aims to understand how well the drug works (pharmacokinetics) and its safety across participants with normal kidneys versus those with varying degrees of renal dysfunction.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally such trials monitor for changes in vital signs, potential allergic reactions to the medication being tested (VIR-2218), impacts on other organs' functions due to altered drug processing by impaired kidneys, and any new symptoms that arise post-treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is normal, with an eGFR of 90 or above.
Select...
My kidney function is reduced, with eGFR between 15-59 mL/min/1.73m2.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Amount excreted in urine for VIR-2218 and its metabolite AS(N-1)3'VIR-2218
Area Under The Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and metabolite AS(N-1)3'VIR-2218
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of VIR-2218 metabolite AS(N-1)3'VIR-2218
+3 moreSecondary outcome measures
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Side effects data
From 2020 Phase 1 & 2 trial • 82 Patients • NCT0367218850%
Headache
17%
Abdominal discomfort
17%
Dry throat
17%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A SAD: VIR-2218 100 mg
Part B MAD: VIR-2218 20 mg
Part A SAD: VIR-2218 50 mg
Part A SAD: VIR-2218 200 mg
Part A SAD: VIR-2218 400 mg
Part A SAD: VIR-2218 600 mg
Part A SAD: VIR-2218 900 mg
Part A SAD: Placebo
Part B MAD: VIR-2218 50 mg
Part B MAD: VIR-2218 100 mg
Part B MAD: VIR-2218 200 mg
Part C MAD: VIR-2218 50 mg
Part C MAD: VIR-2218 200 mg
Part B MAD: Placebo
Part C MAD: Placebo
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional)Experimental Treatment1 Intervention
Group II: Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participantsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VIR-2218
2020
Completed Phase 2
~110
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Vir Biotechnology, Inc.Lead Sponsor
27 Previous Clinical Trials
13,232 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function has been stable recently.I have had a bone marrow or organ transplant.I have severe kidney disease or am on dialysis.I haven't taken any medications except vitamins or birth control in the last 30 days.My kidney function is normal, with an eGFR of 90 or above.I agree to follow the study's birth control requirements.My doctor thinks I am healthy enough to join the study, including if I have kidney issues.I have uncontrolled high blood pressure, asthma, or diabetes.My kidney function is reduced, with eGFR between 15-59 mL/min/1.73m2.I have stable heart function without significant heart failure.You have diabetes.I currently have an active cancer.I have an infection with HIV or hepatitis viruses.I currently have signs of an active infection.I currently have active inflammation of my kidneys.I have a serious liver condition.You have a history of using drugs or drinking too much alcohol.I have vasculitis or a condition related to vasculitis.I had major surgery less than a year ago.My medication doses for chronic conditions haven't changed in the last 2 weeks.Your body mass index (BMI) should be between 18.5 and 35.0 kg/m2.I can sign a consent form understanding the trial's details.I have had stable kidney problems for at least 3 months.I do not have any health or mental conditions that could affect my participation.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2: 8 severe Renal Impairment (RI) participants and 8 matched healthy participants (optional)
- Group 2: Cohort 1: 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA recognize Cohort 1, which is composed of 8 moderately impaired renal individuals and their matched counterparts?
"Limited clinical data exists to support the efficacy and safety of Cohort 1: 8 moderate Renal Impairment (RI) patients and 8 participants without renal impairment. As such, our team assigned it a score of 1 on a scale from 1-3."
Answered by AI
Could I potentially qualify for this medical study?
"Prospective participants for this trial must have kidney failure and be aged between 18 and 70. The total number of enrollees is 32 individuals."
Answered by AI
Is participation being accepted from minors in this clinical trial?
"The requirements for enrolment in this investigation dictate that participants must be aged 18 to 70. Additionally, there are 6 separate studies available for minors and 154 specialised trials specifically catered towards the elderly population."
Answered by AI
Could individuals still become part of this research project?
"As revealed on clinicaltrials.gov, the deadline for patient enrolment in this medical trial has elapsed as it was last updated on April 24th of 2023. However, there are presently 161 other trials recruiting participants at present time."
Answered by AI
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