Peritoneal dialysis patients
Conditions
Interventions
Pyridoxamine (200 mg) is orally administered at 3 times daily for 7 days.
Sponsors
Fukushima Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients stably receiving peritoneal dialysis at least for 3 months. 2. Patients who provided voluntary informed consent to participate in the trial. 3. Patients aged more than or equal to 20 years and less than 80 years old. 4. Patients who are not taking vitamin B6 more than 4 weeks.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of oral pyridoxamine at the beginning and 7 days after administration of pyridoxamine (Changes in concentration of vitamin B6 and unchanged drug). | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of carbonyl stress-related biomarkers in blood and the abdominal cavity at the beginning, 4 and 7 days after administration of pyridoxamine. | — |
Countries
Japan
Contacts
Public ContactMasaaki Nakayama
Fukushima Medical University Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Outcome results
None listed