A Phase 3 open-label, controlled, randomised, multi-centre trial comparing imlifidase and standard-of-care with standard-of-care alone in the treatment of severe anti-GBM antibody disease (Goodpasture disease)

Anti-GBM antibody disease (Goodpasture disease)

Renal function as evaluated by eGFR at 6 months

Proportion of patients with functioning kidney at 6 months, i.e. no dialysis events within 4 weeks prior to assessment, Time to non-toxic level of anti-GBM antibodies, Exposure to toxic level of anti-GBM antibodies, Renal function as evaluated by eGFR at 3 months, Proportion of patients with functioning kidney at 3 months, i.e. no dialysis event within 4 weeks prior to assessment, Proportion of patients experiencing ESRD or death due to anti-GBM disease within 6 months, Urine creatinine clearance from randomisation to 3 and 6 months, U-albumin at 3 and 6 months (24h collection), U-albumin/creatinine ratio at screening and during study (morning urine void), Renal function as evaluated by eGFR at screening and during study, Number of PLEX sessions within 3 months from randomisation, Number of days on dialysis within 3 and 6 months from randomisation, Proportion of patients being negative during study for: Anti-GBM antibodies; ANCA;Anti-GBM antibodies and ANCA, Number of days with mechanical ventilation due to anti-GBM disease within 3 months from randomisation, Number of days at ICU and number of days in hospitalisation from randomisation to 3 months, HRQoL and health status as evaluated by PROMIS-29 and EQ-5D-5L from screening to 6 months, Imlifidase PK data from start of imlifidase treatment to Day 15, Imlifidase PD (IgG) profile from start of imlifidase treatment to Day 15, Anti-imlifidase antibody levels from start of imlifidase treatment to 6 months

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