A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
Recruiting
Phase 2Interventional Study
Nephrotic Syndrome Due to Idiopathic Membranous NephropathySevere Proteinuria Due to Idiopathic Membranous Nephropathy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
23 (estimated)
Sponsor
SynAct Pharma Aps · Industry
Who this trial is looking for
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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.
Trial Locations
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Eligibility 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
* Diagnosed as anti-PLA2-Receptor positive by local laboratory within 6 months p…
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
* 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.
Exclusion Criteria:
* 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.
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