Status:
RECRUITING
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Treatment With AP1189 in Patients With iMN and Severe Proteinuria
Lead Sponsor:
SynAct Pharma Aps
Conditions:
Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy
Severe Proteinuria Due to Idiopathic Membranous Nephropathy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 ne...
Detailed 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 ne...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04456816
Start Date
August 31 2020
End Date
June 30 2026
Last Update
December 9 2024
Active Locations (1)
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1
Aarhus Universitetshospital
Aarhus, Denmark, 8200