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

NCT04456816 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy
  • Severe Proteinuria Due to Idiopathic Membranous Nephropathy

Interventions

DRUG

100 mg AP1189

100 mg AP1189 tablet

DRUG

Placebo

Matching placebo tablet

Sponsors & Collaborators

  • SynAct Pharma Aps

    lead INDUSTRY

Principal Investigators

  • Henrik Birn, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-31
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04456816 on ClinicalTrials.gov