Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients (APPLAUSE-IgAN)

Brief Summary:
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

Detailed Description:
This trial is a multicenter, randomized, double-blind, placebo controlled parallel group study. 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. 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. 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. 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. 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). Estimated GFR decline will be calculated using the CKD-EPI formula. 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.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: January 25, 2021
Estimated Primary Completion Date: January 7, 2025
Estimated Study Completion Date: January 14, 2025

Arm:
- Experimental: LNP023 200mg b.i.d
- Placebo Comparator: Placebo to LNP023 200mg b.i.d

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