Efficacy and Safety of LNP023 Compared With Rituximab in Subjects With Idiopathic Membranous Nephropathy
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT04154787
- Phase
- PHASE2
- Status
- Terminated
Conditions
- Idiopathic Membranous Nephropathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- LNP023 — DRUGInvestigation of LNP023
- Rituximab — DRUGComparison of rituximab dose
Study Details
This was a randomized, open-label, two arm, parallel group, proof-of-concept, nonconfirmatory study evaluating the efficacy and safety of LNP023 compared with rituximab in subjects with Idiopathic (primary) membranous nephropathy (iMN) who are at high risk of disease progression defined on the basis of anti- Phospholipase A2 Receptor (PLA2R) antibody titer ≥ 60 RU/mL and proteinuria with urine protein (UP) ≥ 3.5 g/24h.
Key Dates
- Start date
- Nov 23, 2019
- Status verified
- Oct 2024
- Primary completion
- Jan 20, 2023
- Completion
- Jan 20, 2023
Study Design
- Enrollment
- 37 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LNP023As per protocol V00, participants took LNP023 10 mg orally b.i.d. for 4 weeks followed by LNP023 50 mg orally b.i.d. for 20 weeks. As per protocol amendment V01, participants took LNP023 50mg orally b.i.d. for 4 weeks followed by LNP023 200mg for 20 weeks.
- Active Comparator: RituximabRituximab 1 g i.v. at Day 1 and Day 15
Primary Outcome Measure
Ratio Between Baseline Urine Protein Creatinine Ratio (UPCR) and Urine Protein Creatinine Ratio at 24 Weeks of Treatment (From 24h Urine Collection) [ Time Frame: Baseline, Day 113, Day 169 ]