An exploratory study for pharmacokinetics, efficacy, and safety of pyridoxamine in peritoneal dialysis patients
- Conditions
- Peritoneal dialysis
- Registration Number
- JPRN-UMIN000023794
- Lead Sponsor
- The University of Tokyo Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The change of blood concentration of pyridoxamine until 6 month after starting administration of pyridoxamine.
- Secondary Outcome Measures
Name Time Method