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VIR-2218 for Kidney Impairment
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 & 2 trial • 82 Patients • NCT03672188Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- 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.
- 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
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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