EUCTR2020-000971-18-NO进行中（未招募）1 期
An exploratory, randomized, double-blind, multicenter, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and efficacy of AP1189 daily doses versus placebo administered for 4 weeks as an add-on to patients, in ACE inhibitor or angiotensin II receptor blocker treatment, with idiopathic membranous nephropathy - SynAct-CS003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent has been obtained prior to initiating any study-specific procedures
- •2.Male and female subjects, 18 to 85 years of age with a renal biopsy consistent with iMN
- •3.Diagnosed as anti-PLA2-Receptor positive by local laboratory
- •4.Nephrotic syndrome defined by a U-protein/creatinine ratio >3.5 g/g and/or U-albumin/creatinine ratio >2.2 g/g and P-albumin below the lower normal limit
- •5.eGFR > 30 ml/min/1.73m2
- •6.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 effects
- •7.Females of child-bearing potential using reliable means of contraception (for detailed information see section 22.8) or are post-menopausal (menstrual periods stopped at least 12 months ahead of the enrolment in the trial) or are surgically sterilized (the procedure must have been performed at least 6 months prior to screening)
- •8.Females of childbearing potential with negative pregnancy test at screening and baseline
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •1.Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry
- •2.Major surgery within 8 weeks prior to screening or planned surgery within one month following randomization
- •3.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”
- •4.Treated with systemic (oral, intramuscular or IV) corticosteroids, or other immune suppressive, or immune modulating compounds within 4 weeks (8 weeks for IV cyclophosphamide) prior to screening (and during the entire treatment period and until the final visit)
- •5.Treated with rituximab within 12 months of screening
- •6.Evidence of active malignant disease (except basal cell carcinoma of the skin that has been excised and cured).
- •7.Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
- •8.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
- •9.Pregnant women or nursing (breastfeeding) mothers
- •10.History of alcohol, drug, or chemical abuse within the 6 months prior to screening
- •11.Any condition that in the view of the investigator would suggest that the patient is unable to comply with study protocol and procedures (e.g., psychiatric disorders, dementia)
- •12. Any history of sensitivity to the IMP ingredients sucralose, starch, tartrazine, and microcrystalline cellulose
研究者
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