Peritoneal dialysis
Conditions
Interventions
Oral administration of 600mg/day (200mg t.i.d) pyridoxamine for 182 days (6months)
Sponsors
The University of Tokyo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Starble PD more than 3months after starting PD. 2) Written informed concent from the patient. 3) More than 20 years old and less than 80 years old. 4) Without taking vitamin B6 (cessation more than 4 weeks ago).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of blood concentration of pyridoxamine until 6 month after starting administration of pyridoxamine. | — |
Countries
Japan
Contacts
Public ContactYoshifumi Hamasaki
The University of Tokyo Hospital Department of Hemodialysis and Apheresis
Outcome results
None listed