A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

IgA Nephropathy

Primary Endpoint for Interim Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months., Primary Endpoint for Final Analysis: •Annualized total eGFR slope estimated over 24 months.

Secondary Endpoint for Interim Analysis: •Change from baseline in eGFR at 9 months., Secondary Endpoint for Interim Analysis: •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months, without receiving CS/IS or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating Kidney Replacement Therapy (KRT)., Secondary Endpoint for Interim Analysis: •Annualized total eGFR slope estimated over 12 months., Secondary Endpoint for Interim Analysis: •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire., Secondary Endpoint for Interim Analysis: •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to 9 months., Secondary Endpoints for Final Analysis: •Time from randomization to first occurrence of composite kidney failure event, defined as reaching either: - sustained ≥30% decline in eGFR relative to baseline, or - sustained eGFR <15 mL/min/1.73m², or - maintenance dialysis, or - receipt of kidney transplant, or - death from kidney failure., Secondary Endpoints for Final Analysis: •Log-transformed ratio to baseline in UPCR (sampled from 24h urine collection) at 9 months., Secondary Endpoints for Final Analysis: •Proportion of participants reaching UPCR (sampled from 24h urine collection) <1g/g at 9 months without receiving CS/IS, or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRT., Secondary Endpoints for Final Analysis: •Change from baseline to 9 months in the fatigue scale measured by the FACIT-Fatigue questionnaire., Secondary Endpoints for Final Analysis: •Safety endpoints (including adverse events/serious adverse events, safety laboratory parameters, vital signs) collected from baseline to the End of Study (EOS).

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