Study of AP1189 Compared to Placebo for 12 Weeks in Adults With Idiopathic Membranous Nephropathy and Severe Proteinuria on ACE Inhibitor or Angiotensin II Receptor Blocker Treatment

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of AP1189 in patients with idiopathic membranous nephropathy iMN who have severe proteinuria. This exploratory, randomized, double-blind, placebo-controlled study focuses on patients already receiving ACE inhibitor or angiotensin II receptor blocker treatment, aiming to understand how AP1189 affects these patients over a 12-week period. Participants will be randomly assigned in a 21 ratio to receive either 100 mg of AP1189 or a matching placebo daily for 12 weeks, alongside their ongoing treatments. The study is conducted at multiple centers and maintains a triple-blind design to ensure unbiased results. The AP1189 and placebo are administered as tablets taken once each day during the treatment period. During the study, participants will undergo regular monitoring including assessments of adverse events, blood tests for liver enzymes and bilirubin, and measurements of protein levels in urine over 24 hours. Researchers will also track albumin levels in urine. These evaluations occur up to week 12, covering safety and treatment effects. The studys total duration includes screening, 12 weeks of treatment, and follow-up to capture all relevant data on patient health and response to the investigational drug.

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria