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

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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) who are on ACE inhibitor or angiotensin II receptor blocker treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SynAct Pharma Aps

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 and based on a renal biopsy

• Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months prior to inclusion

• Nephrotic syndrome defined by a U-protein/creatinine ratio >3.5 g/g and/or U-albumin/creatinine ratio >2.2 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 2 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

• 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

Exclusion Criteria:

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

• 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