Effects of pyridoxamine for peritoneal injury in patients with peritoneal dialysis: Search of the effective end-point
- Conditions
- Peritoneal Injury in patients with peritoneal dialysis
- Registration Number
- JPRN-UMIN000031730
- Lead Sponsor
- Juntendo Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 10
Not provided
>Combined therapy with PD and hemodialysis >Severe liver disease >Previous severe adverse effect and all allergy >Participating other clinical stadies >Malignancy, or less than 3-years after treatment of the cancer >Less than 6-months from previous cardiovascular disease (myocaridial infarction and apoplexy) >More than 8 years PD, or having enca psulating peritoneal sclerosis. >Peripheral arterial disease (more than class 2 of Fontaine classification). >Uncontrolled hypertension (more than 180mmHg of systolic BP and 120mmHg of diastolic BP). >HbA1c >8.0%. >Severe anemia (Hb <9.0g/dl) >Using aminophylline, theophylline, cholinetheophylline, levodopa, pyridoxa l, pyridoxine, and other vitamin B6 agen ts within 4 weeks. >Expected pregnancy within 1 year. >Others judged to be excluded by doc tors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of D/P creatinine and ultrafiltration rate in peritoneal equilibrium test and net ultrafiltraion volume in 24-hours 3 months after pyridoxamine administration. Changes of pyridoxamine, pyridoxal and pyridoxine in peritoneal effluent and sera 3 months after pyridoxamine administration.
- Secondary Outcome Measures
Name Time Method