WebOct 23, 2024 · Study 4 (CLNP023B12301) Randomized, placebo-controlled, 12-month study (6 months double - blind + 6 months open-label) to evaluate the efficacy and safety of … WebCLNP023B12301. Pediatrics Nephrology Kidney Disease Adult Subjects The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy. VT-001-0050 Atacicept IgA Nephropathy ORIGIN ...

ICH GCP - EU Clinical trials Registry - 2024-004589-21 (GR)

WebCLNP023B12301 : Brief Title: Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. (APPEAR-C3G) Official Title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy. Secondary IDs: WebCLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants … familotel bischofsmais

History of Changes for Study: NCT04817618

WebCLNP023B12301 is a Phase 3 pivotal trial for registration of iptacopan in C3G. The study aims to determine the reduction in UPCR and improvement in eGFR in participants … WebMust have clinical and pathologic evidence of recurrent C3G or IC-MPGN. Stable (not improving) or worsening disease, in the opinion of the investigator, in the 2 months … Web13) Change from Day 180 in study CLNP023B12301 in eGFR over time (placebo arm of study CLNP023B12301). 14) A participant is defined as meeting the requirements of the composite renal endpoint if they satisfy the eGFR (a stable or improved eGFR, i.e., ≤15% reduction in eGFR compared to the baseline visit) and UPCR (≥50% reduction in UPCR ... conyとは