Proportion of participants reaching Urine Protein-To-Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant Therapy or other newly approved drugs or initiating new background therapy for treatment of IgAN or initiating KRTĬhange from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire. Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months Time from randomization to first occurrence of composite kidney failure endpoint event Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g without receiving Corticosteroids/Immunosuppressant or other newly approved drugs or initiating new background therapy for treatment of IgAN or Kidney Replacement Therapy (KRT)Īnnualized total Estimated Glomerular Filtration Rate slope estimated over 12 monthsĬhange from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 monthsĪnnualized total estimated Glomerular Filtration Rate (eGFR) slope over 24 months).
The SRI population will not be included in the efficacy analyses of the main study population it will primarily provide additional PK and safety information for SRI participants. Estimated GFR decline will be calculated using the CKD-EPI formula.
#Applause igan trial
The trial will enroll approximately 450 participants 430 biopsy-proven IgAN participants with eGFR ≥30 mL /min/1.73m2 (main study population) and approximately 20 participants with eGFR 20 to <30 mL/min/1.73m2 (severe renal impairment (SRI) population). The trial will continue in a blinded fashion to confirm long-term efficacy based on annualized total slope of eGFR decline over 24 months to provide confirmatory evidence of LNP023 efficacy and safety in treating patients with IgAN. placebo as assessed by reduction in urine protein to creatinine ratio (UPCR) sampled from a 24 hour urine collection at an IA at 9 months.
#Applause igan registration
The study will be the pivotal trial for registration of LNP023 in IgA Nephropathy patients with the aim to demonstrate a clinically meaningful reduction in proteinuria by LNP023 vs. The purpose of the study is to evaluate the efficacy and safety of LNP023 compared to placebo on proteinuria reduction and slowing disease progression in primary IgAN patients. This trial is a multicenter, randomized, double-blind, placebo controlled parallel group study.
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