Crovalimab Trial Results in Pediatric aHUS Show Dialysis Changes

ClinicalTrials.gov posted results on 9 September 2026 for a Phase 3 study evaluating crovalimab in pediatric participants with atypical hemolytic uremic syndrome (aHUS). The 41-participant study reported dialysis-status measurements after 24 weeks of treatment, including 37.5% in the crovalimab-naïve cohort and 0% in the switch cohort for one reported endpoint.

Background

The study evaluated crovalimab, also identified as Piasky, in pediatric participants with aHUS. Its stated aims were to assess efficacy, safety, pharmacokinetics, and pharmacodynamics. The record describes both participants who were naïve to crovalimab and participants who switched to it.

Trial design

This Phase 3 study, identified as NCT04958265, enrolled 41 participants with atypical hemolytic uremic syndrome. Crovalimab was the listed intervention. The study status was active, not recruiting, and the record supplied no primary-outcome entries. Reported measurements covered dialysis status at baseline or Week 25 among participants who completed 24 weeks of treatment, as well as change from baseline to Week 25.

Key results

For the endpoint measuring the percentage of participants requiring dialysis at baseline or Week 25 and completing 24 weeks of treatment, the reported values were 37.5% for the crovalimab-naïve cohort and 0% for the crovalimab switch cohort. Additional entries for the same endpoint reported 0% in both cohorts.

For change from baseline to Week 25 in dialysis status, the record reported values of 0% for the naïve cohort and 0% for the switch cohort in one set of entries. Other reported values were 37.5% for the naïve cohort and 0% for the switch cohort, followed by 0% for the naïve cohort and 62.5% for the switch cohort. A further set reported 100% for the switch cohort. The supplied measurements did not include dispersion values, p-values, confidence-interval values, or comparative analyses.

What this means

The posted record provides dialysis-status measurements for pediatric participants with aHUS treated with crovalimab, separated into naïve and switch cohorts. Because the supplied data do not include primary-outcome entries, adverse-event results, sample sizes for each cohort, or statistical comparisons, they do not establish comparative efficacy or safety between the cohorts.

Source

Source: ClinicalTrials.gov, registry results for the Phase 3 study evaluating crovalimab in pediatric participants with atypical hemolytic uremic syndrome, posted 9 September 2026. Available at clinicaltrials.gov/study/NCT04958265.