JPRN-jRCT2080225039已完成3 期
Cross-over study of PDLYMT in chronic kidney disease (CKD) patients undergoing hemodialysis therapy
IPRO CORPORATIO0 个研究点目标入组 53 人开始时间: 2020年1月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
It was shown that PDLYMT has a similar effect on removing uremic substances to TA3, and that PDLYMT can correct the serum electrolytes and blood acid-base balance within a clinically appropriate range, reflecting the composition of this drug. In addition, there was no difference in the incidence of adverse events between PDLYMT and TA3, indicating that PDLYMT can be used safely in dialysis treatment as well as TA3.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 84age old(—)
- 性别
- All
入选标准
- •Patients providing written informed consent about participation in this clinical study
- •- Patients aged 20 to 84 years old at the time of informed consent
排除标准
- •- Patients within 3 months of initiating hemodialysis at the time of informed consent
- •- Patients who find it difficult to undergo HD stably during the entire duration of this study
- •- Patients who are pregnant or who have the possibility of pregnancy at the time of informed consent
- •- Patients participating in clinical studies of other drugs, medical devices, etc. at the time of informed consent for this study
- •- Patients who may not be able to be evaluated as described in the protocol due to serious disease
- •- Patients judged by the investigator or sub-investigator to be inadequate for this study
研究者
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