A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP118
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.
| Condition(s) | Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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 D |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | SynAct Pharma Aps |
| Locations | Aarhus, Denmark |
| Start date | 2020-08-31 |
| NCT ID | NCT04456816 |
| Official listing | https://clinicaltrials.gov/study/NCT04456816 |