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

Recruiting Phase 2 Interventional Study
Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy Severe Proteinuria Due to Idiopathic Membranous Nephropathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
23 (estimated)
Sponsor
SynAct Pharma Aps · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 p…
Contacts

Irene Sandholdt

+45 2015 7033

isa@croxxmed.com

CONTACT

Birgitte Telmer, MD

+45 2015 1221

bte@croxxmed.com

CONTACT