Renal ImpairmentPhase 1NCT05844228
A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
A Phase 1 study testing VIR-2218 in people with Renal Impairment, run by Vir Biotechnology, Inc. at 3 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- VIR-2218
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2023to 21 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Inclusion Criteria: Additional Criteria Specific to Healthy Participants:
- Must be in the opinion of the investigator, be in good health based upon medical history, vital signs, physical examination, and screening laboratory evaluations
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- 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.
- Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
- 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
Who cannot join
- 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
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- 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
- Exclusion Criteria: Additional Criteria Specific to Healthy Participants
- 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
- Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Floridian Clinical Research
Miami Lakes, Florida, 33016
Orlando Clinical Research Center
Orlando, Florida, 32809
Inland Empire Clinical Trials
Rialto, California, 92377
About this study
Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 in Adult Participants With Renal Impairment
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
Read the detailed description
Participants may be enrolled in Cohorts 1 and 2 in a non-randomized way.
- Conditions
- Renal Impairment
- Being tested
- VIR-2218
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-2218Drug
Also called Elebsiran
VIR-2218 given by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Up to 8 moderate Renal Impairment participants and up to 8 matched healthy participants | Experimental | Not described Receives: Drug: VIR-2218 |
| Cohort 2: Up to 8 severe Renal Impairment participants and up to 8 matched healthy participants | Experimental | Not described Receives: Drug: VIR-2218 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Measured: 4 days
Area Under The Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Measured: 4 days
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Measured: 4 days
Fraction Excreted in Urine in Percentage for VIR-2218
Measured: 4 days
Amount Excreted in Urine for VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Measured: 4 days
Renal Clearance for VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Measured: 4 days
Secondary outcomes (1)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023
- Primary completion1 Mar 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844228
- Sponsor's protocol ID
- VIR-2218-V108
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2023
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose, Parallel-Group Study of the Pharmacokinetics and Safety of VIR-2218 in Adult Participants With Renal Impairment
- ClinicalTrials.gov ID
- NCT05844228
- Acronym / sponsor ID
- VIR-2218-V108
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Posted 16 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Up to 8 moderate Renal Impairment participants and up to 8 matched healthy participants | Experimental | Drug: VIR-2218 |
| Cohort 2: Up to 8 severe Renal Impairment participants and up to 8 matched healthy participants | Experimental | Drug: VIR-2218 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIR-2218Also: ElebsiranVIR-2218 given by subcutaneous injection | Drug | Cohort 1: Up to 8 moderate Renal Impairment participants and up to 8 matched healthy participants, Cohort 2: Up to 8 severe Renal Impairment participants and up to 8 matched healthy participants |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Time frame: 4 days
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Area Under The Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Time frame: 4 days
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Time frame: 4 days
Pharmacokinetic samples were collected at -2 hours pre-dose and at 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours post-dose.
Fraction Excreted in Urine in Percentage for VIR-2218
Time frame: 4 days
Amount Excreted in Urine for VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Time frame: 4 days
Renal Clearance for VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218
Time frame: 4 days
1 secondary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIR-2218 in people with Renal Impairment, run by Vir Biotechnology, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) of VIR-2218 and Its Metabolite AS(N-1)3'VIR-2218 (time frame: 4 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.