Recruiting NCT04456816

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

Phase II Interventional Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy Severe Proteinuria Due to Idiopathic Membranous Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 100 mg AP1189, Placebo.
Who it may be relevant to: Registry conditions: Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy. Basic parameters: 18 years — 85 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Denmark
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

An Exploratory, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AP1189 Versus Placebo Administered for 12 Weeks as an add-on to Patients, in ACE Inhibitor or Angiotensin II Receptor Blocker Treatment, With Idiopathic Membranous Nephropathy and Severe Proteinuria

Overview

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.

Detailed description

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 12 weeks (28 days) as an add-on to any ongoing treatment, including ACE inhibitors/ angiotensin II receptor blocker * Group B (6 subjects): placebo for 12 weeks (28 days) as an add-on to any ongoing treatment including ACE inhibitors/ angiotensin II receptor blocker.

Interventions

Drug 100 mg AP1189
100 mg AP1189 tablet
Drug Placebo
Matching placebo tablet

Primary outcome measures

Adverse Event [Time frame: Week 12]
Serious Adverse Events [Time frame: Week 12]
ALAT change in plasma samples [Time frame: Week 12]
ASAT change in plasma samples [Time frame: Week 12]
Total bilirubin change in plasma samples [Time frame: Week 12]
Alkaline phosphatase change in plasma samples [Time frame: Week 12]
Protein change in 24 hours urinary protein excretion [Time frame: Week 12]

Secondary outcome measures (1)

Albumin change in 24 hours urinary protein excretion [Time frame: Week 12]

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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment

Study locations

Denmark · 1 center

Aarhus Universitetshospital — Aarhus

Identifiers

NCT: NCT04456816 · SynAct-CS003

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗