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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    23
  • sponsor
    SynAct Pharma Aps
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Updated on 25 January 2021
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ace inhibitor
angiotensin
protein creatinine ratio
kidney biopsy
nephrotic syndrome

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.

Description

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.

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 4 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker
  • Group B (6 subjects): placebo for 4 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.

Details
Condition Membranous glomerulonephritis, Idiopathic Membranous Nephropathy
Treatment Placebo, 100 mg AP1189
Clinical Study IdentifierNCT04456816
SponsorSynAct Pharma Aps
Last Modified on25 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 85 yrs?
Gender: Male or Female
Do you have any of these conditions: Idiopathic Membranous Nephropathy or Membranous glomerulonephritis?
Do you have any of these conditions: Membranous glomerulonephritis or Idiopathic Membranous Nephropathy?
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
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