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

NCT ID: NCT05844228

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-04-21

Brief 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

Detailed Description

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

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Up to 8 moderate Renal Impairment (RI) participants and 8 matched healthy participants

Group Type: EXPERIMENTAL

VIR-2218

Intervention Type: DRUG

VIR-2218 given by subcutaneous injection

Cohort 2: Up to 8 severe Renal Impairment (RI) participants and 6 matched healthy participants

Group Type: EXPERIMENTAL

VIR-2218

Intervention Type: DRUG

VIR-2218 given by subcutaneous injection

Interventions

VIR-2218

VIR-2218 given by subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Elebsiran

Eligibility Criteria

Inclusion Criteria

• Participants must have stable renal function as defined by less than 20% change in estimated glomerular filtration rate (eGFR) between the first and second screening sample with the first screening visit occurring within 28 days prior to dosing on Day 1 and the second screening visit occurring no more than 14 days apart, but at least 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

• Must be in the opinion of the investigator, be in good health based upon medical history, 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 the Modification of Diet in Renal Disease (MDRD) equation determined from the mean of two measurements of serum creatinine at screening.

• Participants must, in the opinion of the investigator, be sufficiently healthy for study participation based on medical history, physical examination, vital signs, and screening laboratory evaluations
• Participants with RI must have chronic moderate or severe RI and be clinically stable 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 MDRD equation, or
• Severe RI as defined by eGFR level 15-29mL/min/1.73m^2 based on the MDRD equation

Exclusion Criteria

• Any clinically significant medical condition or psychiatric condition that may interfere 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 significant heart 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 have undergone or are listed for transplant, or participants who have chronic kidney disease 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

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

• Not on stable dose and regimen of any medication(s) (prescription or over-the-counter) that the participants is taking regularly (eg, medications for chronic conditions such as hypertension, high cholesterol, or depression must not be changed 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 not for chronic conditions (with the exception of vitamins and/or hormonal contraceptive medications) including herbal products within 30 days prior to D1 of study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vir Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inland Empire Clinical Trials

Rialto, California, United States

Floridian Clinical Research

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Other Identifiers

VIR-2218-V108

Identifier Type: -

Identifier Source: org_study_id