This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Anti-GBM antibodies detected by ELISA above a level that is considered toxic by the investigator using local laboratory. Patients double-positive for anti-GBM and anti-neutrophil cytoplasmic antibodies (ANCAs) may be entered in the trial, but only if their level of anti-GBM antibodies fulfil the criteria listed above.
✓. Estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73 m\^2 (by modification of diet in renal disease (MDRD) equation) or if the patient is non-responsive to standard treatment, and has lost \>15 ml/min/1.73 m\^2 after start of treatment
✓. Haematuria on dipstick and/or urinary sediment
✓. Male or female patients aged at least 18 years; Female patients of childbearing potential may participate if highly effective contraception is used during the study, according to Clinical Trials Facilitation and Coordination Group (CTFG) guidance \[18\], see also section 4.9 (pregnancy test should be performed before inclusion).
✓. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol; and
Exclusion criteria
✕. Anuria for more than 2 days (less than 200 ml during last 48 hours);
✕. Dialysis dependency for more than 5 days (maximum 3 sessions before signing informed consent);
✕. Ongoing moderate to severe pulmonary haemorrhage (or having ceased within the last two weeks), defined as requiring assisted ventilation, oxygen or blood transfusions.
✕. Pregnancy.
What they're measuring
1
Number of Patients With Independent Renal Function at 6 Months
. Symptomatic congestive heart failure (NYHA class 2-4) and requiring prescription medication or clinically evident peripheral edema of cardiac origin;
✕. Myocardial infarction, unstable angina or stroke within 3 months prior to screening;
✕. Ongoing bacterial infection requiring antibiotic therapy or viral infection with Hepatitis B, C or HIV (up to 3 months old negative test results are accepted); or active tuberculosis as indicated by chest x-ray.
✕. Patients should not have received investigational drugs within 30 days prior to screening or within 4 half-lives (whichever is longer); and