JPRN-jRCTs061230094尚未招募Unknown
A clinical study to evaluate the effect of dantrolene sodium hydrate on kidney function and albuminuria in patients with moderately to severely reduced kidney function
chinoumi Hitoshi0 个研究点目标入组 15 人开始时间: 2024年1月29日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
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. Chronic Kidney Disease (CKD) patients who receive treatment according Evidence-based Clinical Practice Guideline for CKD 2018.
- •2. Female or male aged >=20 years at the time of consent
- •3. eGFR >=25 and <=45 mL/min/1.73m2 at visit 0 or UACR >=200 and <=5000 mg/gCr at visit 0
- •4. Provision of signed informed consent prior to any study specific procedures
- •5. Out-patient of Yamaguchi university hospital
排除标准
- •1) Patient who should receive therapy with immune suppressive drugs (e.g. prednisolone >= 5 mg/day or equivalent) who primary investigator and investigators consider as unstable condition of the disease.
- •2) History of receiving therapy with immune suppressive drugs (e.g. prednisolone >= 5 mg/day or equivalent) within 3 months of obtaining informed consent
- •3) UPCR (urinary protein-to-creatinine ratio: g/gCr) measured from spot urine sample >= 3.0 at screening period
- •4) Acute renal failure
- •5) Drug-induced renal dysfunction
- •6) Continuously receiving hemodialysis and peritoneal dialysis or is planned to receive these renal replacement therapy
- •7) History of renal transplantation, or is planned to receive this surgery during the present study
- •8) Uncontrollable diabetes mellitus, hypertension or hyperthyroidism
- •9) Receiving therapy with acute heart failure or lethal arrhythmia
- •10) COPD and severe respiratory dysfunction
- •11) Diagnosed with myasthenia graves
- •12) Severe liver dysfunction
- •14) Patient who could not receive oral medication
- •15) History of allergy and hypersensitivity for dantrolene
- •16) Pregnant or potentially pregnant women or breastfeeding
- •17) History of acute coronary syndrome, stroke, transient ischemic attack within 3 months prior to obtaining informed consent
- •18) Cardiac, carotid, or other major CV surgery (surgical/transcatheter) was performed within 3 months of obtaining informed consent or is planned to receive these surgery within the 3 months after obtaining informed consent
- •19) Severe inflammatory disease such as sepsis and pneumonia etc.
- •20) Active cancer
- •21) Patient who primary investigator and investigators consider as unsuitable for the present study
研究者
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