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Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation

IgA Nephropathy Clinical Trial

Official title:
An Adaptive Seamless Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Investigate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

Clinical Trial Summary

Efficacy and safety of LNP023 in IgAN patients

Clinical Trial Description

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study with an adaptive design (Part 1 informed the design adaptations for Part 2). In Part 1, three doses of LNP023 (10 mg, 50 mg, and 200 mg) vs. placebo control were compared; In Part 2, four doses of LNP023 (10 mg, 50 mg, 100 mg, and 200 mg) vs. placebo control were compared. The study comprised a run-in phase in order that patients were on stable and maximally tolerated dose of Angiotensin-converting-enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for at least 90 days, a 90 days treatment phase in Part 1; a 180 days treatment phase in Part 2 and a 90 days follow-up phase in both Parts 1 and 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03373461
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date February 7, 2018
Completion date June 22, 2021
View Details
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