A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218

Last updated: June 10, 2025
Sponsor: Vir Biotechnology, Inc.
Overall Status: Completed

Phase

1

Condition

Kidney Failure

Kidney Disease

Nephropathy

Treatment

VIR-2218

Clinical Study ID

NCT05844228
VIR-2218-V108
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are otherwise medically stable

Eligibility Criteria

Inclusion

Inclusion Criteria for All Participants:

  • Participants must have stable renal function as defined by less than 20% change inestimated glomerular filtration rate (eGFR) between the first and second screeningsample with the first screening visit occurring within 28 days prior to dosing onDay 1 and the second screening visit occurring no more than 14 days apart, but atleast 72 hours apart from the first.

  • Body mass index (BMI) within the range 18.5 to 40.0 kg/m^2 at screening.

  • Female and Male participants must consent to follow contraception requirements

  • Capability of giving signed informed consent form

Inclusion Criteria: Additional Criteria Specific to Healthy Participants:

  • Must be in the opinion of the investigator, be in good health based upon medicalhistory, vital signs, physical examination, and screening laboratory evaluations

  • Must have normal renal function as defined by eGFR ≥ 90 mL/min/1.73m^2 based on theModification of Diet in Renal Disease (MDRD) equation determined from the mean oftwo measurements of serum creatinine at screening.

Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment

  • Participants must, in the opinion of the investigator, be sufficiently healthy forstudy participation based on medical history, physical examination, vital signs, andscreening laboratory evaluations

  • Participants with RI must have chronic moderate or severe RI and be clinicallystable per investigator assessment for at least 3 months prior to screening

  • Moderate RI as defined by eGFR level 30-59 mL/min/1.73m^2 based on the MDRDequation, or

  • Severe RI as defined by eGFR level 15-29mL/min/1.73m^2 based on the MDRD equation

Exclusion

Exclusion Criteria: Criteria for All Participants

  • Any clinically significant medical condition or psychiatric condition that mayinterfere with study intervention

  • Participants with uncontrolled hypertension, asthma, and/or diabetes (Type I or II).

  • Participants with diabetes

  • Participants with any active malignancy

  • Participants with vasculitis or conditions associated with vasculitis.

  • Participants who have undergone major surgery within 12 months of screening

  • Participants with unstable cardiac functions, abnormality, or clinically significantheart failure

  • Participants with infection of HIV, HAV, HBV, HCV, HDV, or HEV

  • Participants with signs of active infection

  • History of bone marrow or solid organ transplantation

  • Participants with end-stage renal disease or nephrotic syndrome as defined by:participants requiring hemodialysis or peritoneal dialysis, participants who haveundergone or are listed for transplant, or participants who have chronic kidneydisease with nephrotic syndrome

  • Participants with active nephritis

  • Participants with clinically significant liver disease

  • History of drug or alcohol abuse

  • Unwillingness or inability to follow procedures outlined in protocol

Exclusion Criteria: Additional Criteria Specific to Healthy Participants

  • Use of any prescription medications or over-the-counter medications (with theexception of vitamins and/or hormonal contraceptive medications) including herbalproducts within 30 days prior to D1 of study participation

Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment

  • Not on stable dose and regimen of any medication(s) (prescription orover-the-counter) that the participants is taking regularly (eg, medications forchronic conditions such as hypertension, high cholesterol, or depression must not bechanged in dose or type for at least 2 weeks prior to study drug administration).Use of other prescription medications or over-the-counter medications that are notfor chronic conditions (with the exception of vitamins and/or hormonal contraceptivemedications) including herbal products within 30 days prior to D1 of studyparticipation

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: VIR-2218
Phase: 1
Study Start date:
June 01, 2023
Estimated Completion Date:
April 21, 2025

Study Description

Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.

Connect with a study center

  • Inland Empire Clinical Trials

    Rialto, California 92377
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Site Not Available

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