Evaluation of effect of pyridoxamine on reducing carbonyl stress in patients receiving peritoneal dialysis. -Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis
- Conditions
- Peritoneal dialysis patients
- Registration Number
- JPRN-UMIN000020956
- Lead Sponsor
- Fukushima Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Not provided
1. Patients receiving hemodialysis in addition to peritoneal dialysis. 2. Patients with severe liver disease or liver dysfunction (AST, ALT >ULN X1.25) 3. Patients with history of allergy (anaphylactic shock, drug eruption) or severe adverse effects to certain drugs. 4. Patients who use medications containing vitamin B6 or are not able to stop the medications. 5. Patients participating in other clinical trial or received investigational products in the last 16 weeks. 6. Patients having active cancers or received complete resection of cancers in the last 3 years. 7. Patients with history of cardiovascular disease in the last 6 months. 8. Patients receiving peritoneal dialysis for more than 8 years or having suspected encapsulating peritoneal sclerosis. 9. Patients with peripheral arterial disease which is more than Fontaine stageII. 10. Patients with uncontrolled hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 120mmHg) under combination treatment of antihypertensive drugs. 11. Patients with uncontrolled diabetes (HbA1c>8.0%). 12. Patients with anemia (Hb<9g/dl) in which erythropoietin is not effective. 13. Patients received prohibited combined drugs described below in the last 4 weeks. Aminophylline, theophylline, choline, theophylline, levodopa, pyridoxal, pyridoxine, etc. 14. Pregnant women or those intending to become pregnant during the next 1 year. 15. Patients judged as inappropriate candidates for the trial by the principal investigator or the sub-investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of oral pyridoxamine at the beginning and 7 days after administration of pyridoxamine (Changes in concentration of vitamin B6 and unchanged drug).
- Secondary Outcome Measures
Name Time Method Changes of carbonyl stress-related biomarkers in blood and the abdominal cavity at the beginning, 4 and 7 days after administration of pyridoxamine.