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.
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. 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 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker * Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
100 mg AP1189 tablet
Matching placebo tablet
Aarhus Universitetshospital
Aarhus, Denmark
RECRUITINGAdverse Event
Evaluation of Adverse Event
Time frame: Week 12
Serious Adverse Events
Evaluation of Serious Adverse Events
Time frame: Week 12
ALAT change in plasma samples
Evaluation of ALAT compared with baseline
Time frame: Week 12
ASAT change in plasma samples
Evaluation of ASAT compared with baseline
Time frame: Week 12
Total bilirubin change in plasma samples
Evaluation of total bilirubin compared with baseline
Time frame: Week 12
Alkaline phosphatase change in plasma samples
Evaluation of alkaline phosphatase compared with baseline
Time frame: Week 12
Protein change in 24 hours urinary protein excretion
Change of protein in urine excretion compared to baseline measured in 24 h urinary protein excretion
Time frame: Week 12
Albumin change in 24 hours urinary protein excretion
Change of albumin in urine excretion compared to baseline measured in 24 h urinary protein excretion
Time frame: Week 12
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