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

NCT05844228 on ClinicalTrials.gov Phase 1 Vir Biotechnology, Inc. (industry) Started 2023-06-01 Completed

Riskier than 5% of active trials

Model scores of the 29,894 trials active now.

Model score 5% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (233 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2025-04-21, after 2023-06-01 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2025-04-21. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: transplanttransplantationdefined byfunctiondisease
Phrases that lowered it: participantshealthyproductshcvand safety
Sponsor's past termination rate: 12.5% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Design: parallel (raises risk) · Design
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Primary purpose: treatment (raises risk) · Design
Minimum age: 18 (raises risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Disease area, neurology: No (lowers risk) · Disease area
Responsible party: sponsor (lowers risk) · Design

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 80 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 8 (typical: 32)
Sponsor's past termination rate: 12.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 9 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 0 (typical: 1)
Drug has FAERS history: No (typical: 64% yes)
Drug's FAERS reports before start: 0 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 0 (typical: 412.5)
Drug's FAERS reports marked serious: no FAERS history (typical: 85.6%)
Drug's FAERS reports with a death: no FAERS history (typical: 15.9%)

Disease area and drugs

Disease areas: urogenital
Drugs matched to FDA substances: elebsiran

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Study of BPN14770 in Participants With Severe Renal Impairment and Healthy Controls NCT07012005 · started 2025 · scored riskier than 3% of active trials completed
Pharmacokinetics of Islatravir in Participants With Severe Renal Impairment (MK-8591-026) NCT04303156 · started 2020 · scored riskier than 5% of active trials completed
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants. NCT07032272 · started 2025 · scored riskier than 4% of active trials completed
A Multiple-Dose Study of Bulevirtide in Participants With Normal and Impaired Renal Function NCT05760300 · started 2023 · scored riskier than 5% of active trials completed
A Phase I Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD0780 NCT06592482 · started 2024 · scored riskier than 3% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.