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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy

In brief

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.

Key facts

Study ID

NCT04456816

Run by

SynAct Pharma Aps

People needed

23

Starts

2020-08-31

Expected to finish

2026-06-30

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• eGFR > 30 ml/min/1.73m2
• Treated with ACE- inhibitors or angiotensin II receptor blocker for a minimum of 1 months with a stable systemic arterial blood pressure OR treatment with ACE inhibitors and/or angiotensin receptor blocker was excluded or discontinued due to hypotension, intolerance or other side effect
• Only Denmark and Norway:
• Females of child-bearing potential using reliable means of contraception or are post-menopausal
• Females of childbearing potential with negative pregnancy test at screening and baseline
• Only Sweden:
• Post-menopausal women or women who are surgically sterilized.

You may not qualify if…

• 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"
• Treated with systemic corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks prior to screening and during the entire treatment period and until the final visit
• Treated with rituximab within 12 months of screening
• Evidence of active malignant disease
• Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
• Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease
• Pregnant women or nursing mothers
• History of alcohol, drug, or chemical abuse within the 6 months prior to screening
• Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures
• Only Sweden:
• Females of child-bearing potential.

Where it is running

• Aarhus Universitetshospital — Aarhus, Denmark (enrolling)

Full record on ClinicalTrials.gov

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