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

  • STATUS
    Recruiting
  • participants needed
    23
  • sponsor
    SynAct Pharma Aps
Updated on 7 February 2023
ace inhibitor
angiotensin
protein creatinine ratio
kidney biopsy
nephrotic syndrome

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) who are on ACE inhibitor or angiotensin II receptor blocker treatment.

Description

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) who are on ACE inhibitor or angiotensin II receptor blocker treatment.

Following a successful screening, subjects who fulfill the enrollment criteria will be randomized in a 2:1 ratio in group A and B:

  • Group A (12 subjects): AP1189 dose 100 mg, once daily for 4 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
  • Group B (6 subjects): placebo for 4 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.

Details
Condition Idiopathic Membranous Nephropathy, Membranous glomerulonephritis
Treatment Placebo, 100 mg AP1189
Clinical Study IdentifierNCT04456816
SponsorSynAct Pharma Aps
Last Modified on7 February 2023

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