TerminatedPhase 3

A Study With Imlifidase in Anti-GBM Disease

Stopped: Company decision, not due to any safety reason.

United States50 participantsStarted 2022-12-22

Plain-language summary

An open-label, controlled, randomised, multi-centre Phase 3 trial evaluating renal function in patients with severe anti-GBM disease comparing imlifidase and standard of care (SoC) with SoC alone. All patients will remain in the trial for 24 months.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Anti-GBM antibodies constituting an indication for PLEX as judged by the Investigator
✓. Haematuria on dipstick and/or urinary sediment
✓. eGFR(MDRD) \<20 mL/min/1.73 m\^2
✓. Patients aged ≥18 years
✓. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol

Exclusion criteria

✕. Diagnosis of anti-GBM disease more than 14 days prior to randomisation
✕. Anuria during the last 24-hour
✕. Any constituent of SoC given more than 10 days prior to randomisation
✕. IVIg within 4 weeks before randomisation
✕. History or presence of any medical condition or disease which, in the opinion of the investigator, may place the patient at unacceptable risk, or jeopardise the purpose of the study
✕. Patients previously randomised in the study
✕. Unsuitable to participate in the trial for any other reason in the opinion of the investigator
✕. Pregnancy or breast feeding

What they're measuring

Renal function as evaluated by estimated glomerular filtration rate (eGFR) at 6 months

Timeframe: At 6 months after randomisation

Trial details

NCT IDNCT05679401

SponsorHansa Biopharma AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-23

View on ClinicalTrials.gov More Anti-Glomerular Basement Membrane Disease trials