JPRN-jRCT2080223640已完成3 期
A Study of CS-3150 to Evaluate Safety in Japanese Type 2 Diabetic Patients with Macroalbuminuria
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 56
研究概览
简要总结
When CS-3150 was administered to patients with type 2 diabetes and macroalbuminuria taking an ARB or ACE inhibitor for 28 weeks, UACR continued to decrease until the end of treatment, and the proportion of patients with improvement from overt nephropathy to early nephropathy continued to increase until the end of treatment. As for SAEs, none of the events were considered related to study drug. CS-3150 treatment was well-tolerated when initiated at a low dosage and titrated upwards over time.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients aged 20 years or older at the time obtaining informed consent
- •2) Patients diagnosed to have type 2 diabetes mellitus
- •3) Patients who meet any of the following in the laboratory tests (central measurement) at run in period.
- •i.Patients with UACR >= 300 mg/g creatinine and < 1000 mg/g creatinine in the early morning first urine at least twice.
- •ii. Patients with eGFRcreat >= 30 mL/min/1.73 m2
- •4) Hypertensive patients who have been taking an ARB or an ACE inhibitor for at least 12 weeks prior to the study drug administration without changing the dosage and administration.
排除标准
- •1) Patients with type 1 diabetes mellitus
- •2) Patients with secondary glucose tolerance impairment
- •3) Patients diagnosed to have non-diabetic nephropathy
- •4) Patients with secondary hypertension
- •5) Patients who were hospitalized for hyperkalemia within 1 year before informed consent
研究者
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