An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria
This study is an exploratory, randomized, double-blind, multicenter, placebo-controlled study with repeated doses of AP1189. The study population will consist of patients with idiopathic membranous nephropathy (iMN) and severe proteinuria who are on ACE inhibitor or angiotensin II receptor blocker treatment.
• Written informed consent has been obtained prior to initiating any study-specific procedures
• Male and female subjects, 18 to 85 years of age diagnosed with iMN within 6 months prior to inclusion
• Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion
• Severe proteinuria defined by a U-protein/creatinine ratio \>3.0 g/g and/or U-albumin/creatinine ratio \>2.0 g/g and a P-albumin below the lower normal limit
• eGFR \> 30 ml/min/1.73m2
• Treated with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 months with a stable systemic arterial blood pressure OR treatment with ACE inhibitors and/or angiotensin receptor blocker was excluded or discontinued due to hypotension, intolerance or other side effect
⁃ Only Denmark and Norway:
• Females of child-bearing potential using reliable means of contraception or are post-menopausal
• Females of childbearing potential with negative pregnancy test at screening and baseline
⁃ Only Sweden:
• Post-menopausal women or women who are surgically sterilized.