EUCTR2018-002012-27-GB进行中（未招募）1 期
A Single Centre, Open-label, Single-group Exploratory Study of the Safety and Activity of Sparsentan for the Treatment of Incident Patients with Immunoglobulin A Nephropathy - SPARTAN v1.0
niversity of Leicester0 个研究点目标入组 10 人开始时间: 2019年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- •Patient is willing and able to provide signed informed consent
- •Patient can understand written and spoken English.
- •Male and female patients with IgAN aged =18 years
- •Biopsy-proven IgAN, diagnosed within the past 3 months
- •Urine total protein =0.5 g/day and estimated glomerular filtration rate (eGFR) value =30 mL/min/1.73 m2
- •Not previously treated with ACEI and/or ARB therapy OR not treated with ACEI and/or ARB therapy within the past 12 months
- •Women of childbearing potential (WOCBP), beginning at menarche, must agree to the use of one highly reliable (ie, can achieve a failure rate of <1% per year) method of contraception from 7 days prior to the first dose of study medication until 90 days after the last dose of study medication. Highly reliable contraception methods include stable oral, implanted, transdermal, or injected contraceptive hormones associated with inhibition of ovulation, or an intrauterine device (IUD) in place for at least 3 months. One additional barrier method must also be used during sexual activity, such as a diaphragm or diaphragm with spermicide (preferred), or male partner’s use of male condom or male condom with spermicide), from Day 1 until 90 days after the last dose of study medication. WOCBP are defined as those who are fertile, following menarche and until becoming postmenopausal unless permanently sterile; permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as amenorrhoea for more than 24 consecutive months without an alternative medical cause; women on hormone replacement therapy must have a documented plasma follicle-stimulating hormone level =40 mIU/mL. All WOCBP must have a negative pregnancy test at Visit 1 (serum) and Visit 2 (urine, with positive results confirmed by serum).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Secondary cause of IgAN
- •Rapidly progressive glomerulonephritis
- •History of diabetes mellitus or nonfasting blood glucose >10 mmol/L (180 mg/dL)
- •Organ transplantation (with the exception of corneal transplants)
- •Concomitant or recent immunosuppression
- •History of heart failure (NYHA Class II-IV), clinically significant cerebrovascular disease, or coronary artery disease
- •Jaundice, hepatitis, or known hepatobiliary disease
- •Malignancy within the past 2 years
- •Haematocrit <27%, haemoglobin <90 g/L (9 g/dL), or potassium >5.5 mmol/L (5.5 mEq/L)
- •History of alcohol or illicit drug use disorder (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)
- •History of serious side effects or allergic response to any angiotensin II antagonist or endothelin receptor antagonist (ERA)
- •The female patient is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
- •The patient has participated in a study of any investigational product within 28 days prior to screening, or plans to participate in such a study during the course of this study.
- •The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study, including the ability to swallow the IMP whole.
- •The patient, in the opinion of the Investigator, has a medical condition or abnormal clinically significant laboratory screening value not listed above that may interfere with the evaluation of sparsentan safety or activity.
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