JPRN-jRCT2080223878已完成3 期
An Active-controlled, Randomized, Cross-over study of K-LA5
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
研究概览
简要总结
Evaluation of the elimination of substances related to azotemia (BUN, Cre, UA) as the primary endpoint showed K-LA5 was similar to K-4. The incidence of adverse events did not differ between the two agents, and no adverse reactions were observed for K-LA5; thus, K-LA5 was considered to have a similar safety profile to that of K-4.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •(1) Patients with chronic renal failure undergoing hemodialysis for 3 to less than 6 hours per session, 3 times a week, in the last week before the period of pre-observation
- •(2) Patients aged 20 to 80 years old at the time of informed consent
- •(3) Patients providing written informed consent about participation in this clinical study
排除标准
- •(1) Patients within 12 weeks of initiating hemodialysis at the time of informed consent
- •(2) Patients with severe hepatic function impairment
- •(3) Patients with severe heart disease
- •(4) Patients with severe respiratory disorder
- •(5) Female patients who are pregnant, lactating, or who have the possibility of pregnancy which cannot be denied by quantitative hCG blood test at the time of enrollment and allocation, or female patients who cannot prevent conception from the time of informed consent through the period of post-observation
- •(6) Patients participated in another clinical study within 12 weeks before the time of informed consent
- •(7) Patients judged by the investigator or sub-investigator to be inadequate for this study due to any other reasons
研究者
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