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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSynAct Pharma Aps

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry

Clinicial findings that in the opinion of the investigator would suggest condition(s) other than iMN as a major cause of severe proteinuria

Major surgery within 8 weeks prior to screening or planned surgery within 1 month following randomization

Blood pressure with systolic pressure above 160 mmHg and/or diastolic pressure above 100 mmHg despite antihypertensive treatment will in all cases be considered "uncontrolled"

Trial design

Treatments tested in this trial

  • 100 mg AP1189
  • Placebo

Treatment groups

23 Participants
are divided into 2 treatment groups

Sponsors and collaborators