A Study With Imlifidase in Anti-GBM Disease (NCT05679401) | Clinical Trial Compass
TerminatedPhase 3
A Study With Imlifidase in Anti-GBM Disease
Stopped: Company decision, not due to any safety reason.
United States, Austria, Belgium50 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Renal function as evaluated by estimated glomerular filtration rate (eGFR) at 6 months
. 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