NCT02616055终止2 期
Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101 in Subjects With Autosomal Dominant Polycystic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate
研究概览
简要总结
Subjects who received tesevatinib in Study KD019-101 and completed 24 months of treatment will continue on the dose of tesevatinib they were receiving at 24 months on the KD019-101 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must have received 24 months of treatment with tesevatinib on study KD019-
- •(Twenty-four months of study drug treatment includes days without treatment that were allowed by the KD019-101 protocol.)
- •Sexually active subject (male and female) has agreed to use two forms of accepted methods of contraception during the course of the study and for 3 months after the last dose of study drug. Effective birth control includes (a) IUD plus one barrier method; (b) on stable doses of hormonal contraception for at least 3 months (eg, oral, injectable, implant, transdermal) plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
- •Female subjects of childbearing potential have a negative pregnancy test at screening. Females of childbearing potential are defined as sexually mature women without prior hysterectomy or who have had any evidence of menses in the past 12 months. However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, or ovarian suppression.
排除标准
- 未提供
研究组 & 干预措施
50mg Daily
Experimental
One 50mg tesevatinib tablet per day
干预措施: tesevatinib (Drug)
100mg Daily
Experimental
Two 50mg tesevatinib tablets per day
干预措施: tesevatinib (Drug)
150mg M/Th
Experimental
Three 50mg tesevatinib tablets every Monday and Thursday.
干预措施: tesevatinib (Drug)
150mg MWF
Experimental
Three 50mg tesevatinib tablets every Monday, Wednesday and Friday.
干预措施: tesevatinib (Drug)
结局指标
主要结局
Monitor Longitudinal Changes in Estimated Glomerular Filtration Rate
时间窗: 37 Months
Monitor longitudinal changes in estimated glomerular filtration rate (eGFR) in subjects with ADPKD when treated with tesevatinib.
次要结局
- Monitor Longitudinal Changes in Total Kidney Volume(37 Months)
- Number of Subjects Experiencing Adverse Events as a Measure of Safety and Tolerability(37 Months)
研究者
研究点 (6)
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