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临床试验/JPRN-UMIN000023794
JPRN-UMIN000023794已完成未知

An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in peritoneal dialysis patients - An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in PD patients

The University of Tokyo Hospital0 个研究点目标入组 6 人开始时间: 2016年10月15日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
6

研究概览

简要总结

Since it was difficult to measure pyridoxamine concentration, we reported the results of analysis of data other than pyridoxamine at a meeting for investigators of pyridoxamine in dialysis patients.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 80years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1) Combined therapy with PD and hemodialysis. 2) Severe liver disease. 3) Previous severe adverse effect and allergy. 4) Participating other clinical studies. 5) Malignancy, or less than 3 years after treatment of the cancer. 6) Less than 6 months from previous cardiovascular disease (myocardial infarction and apoplexy). 7) More than 8 years PD, or having encapsulating peritoneal sclerosis. 8) Peripheral arterial disease (more than class 2 of Fontaine classification). 9) Uncontrolled hypertension (more than 180mmHg of systolic BP and 120mmHg of diastolic BP). 10) HbA1c >8.0%. 11) Severe anemia (Hb <9.0g/dl) 12) Using aminophylline, theophylline, cholinetheophylline, levodopa, pyridoxal, pyridoxine, and other vitamin B6 agents within 4 weeks. 13) Expected pregnancy within 1 year. 14) Others judged to be excluded by doctors.

研究者

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