Идёт набор NCT04456816

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

Фаза II С лечением Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy Severe Proteinuria Due to Idiopathic Membranous Nephropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: 100 mg AP1189, Placebo.
Кому может быть актуально: Состояния в реестре: Nephrotic Syndrome Due to Idiopathic Membranous Nephropathy, Severe Proteinuria Due to Idiopathic Membranous Nephropathy. Базовые параметры: 18 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Дания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Препарат 100 mg AP1189
100 mg AP1189 tablet
Препарат Placebo
Matching placebo tablet

Первичные конечные точки

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

Вторичные конечные точки (1)

Albumin change in 24 hours urinary protein excretion [Срок оценки: Week 12]

Критерии участия

Критерии включения

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.

Критерии исключения

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: