EUCTR2014-001516-19-NL进行中（未招募）1 期
A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/day, Split dose) in Subjects with Autosomal Dominant Polycystic Kidney Disease
Otsuka Pharmaceutical Development & Commercialization,0 个研究点目标入组 2,500 人开始时间: 2014年11月6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
- 2,500
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
入选标准
- •1. Male and female subjects aged > 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have
- •- Completed and transferred from the double-blind Trial 156-13-210 (12-month period including post-treatment follow-up, regardless of whether this was on-treatment or off-treatment), or
- •- Completed Trial 156-08-271 or a prior tolvaptan trial, or
- •- Interrupted or discontinued treatment in a tolvaptan trial other than Trial 156-13-210. Subjects may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial
- •- Renal function will be assessed during screening by using historical laboratory values (in the last 3 months) for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR). The eGFR values will be estimated based on the Chronic Kidney Disease - Epidemiology (CKD-EPI) formula.
- •2. Estimated glomerular filtration rate > 20 mL/min/1.73 m2 (calculated using the CKD-EPI formula) within 3 months prior to the baseline visit. Subjects who have an eGFR between 15 and 19 mL/min/1.73 m2 may be permitted with documented medical monitor and sponsor approval and increased frequency of monitoring to ensure safety of subjects.
- •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 2400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of IMP. If employing birth control, 2 of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, birth control, pill, birth control implant, birth control depot injection, condom, or sponge with spermicide.
- •2. Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
- •3. Need for chronic diuretic use.
- •4. Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease during screening based on recent historical laboratory values (in the last 3 months).
- •5. Subjects with contraindications to required trial assessments (contraindications to optional assessments, eg, MRI are not a limitation).
- •6. Subjects who, in the opinion of the investigator or medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance. This includes prior evidence of significant hepatic injury deemed to be related to tolvaptan use.
研究者
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