UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of effect of pyridoxamine on reducing carbonyl stress in patients receiving peritoneal dialysis. -Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis -
Title of the study (Brief title)	Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis.
Region	Japan

Condition
Condition	Peritoneal dialysis patients
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. To determine changes in blood concentrations of oral pyridoxamine and effect of daily administration on pharmacokinetics. 2. To estimate the suppressive effect of pyridoxamine for carbonyl stress after daily administration of pyridoxamine.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pharmacokinetics of oral pyridoxamine at the beginning and 7 days after administration of pyridoxamine (Changes in concentration of vitamin B6 and unchanged drug).
Key secondary outcomes	Changes of carbonyl stress-related biomarkers in blood and the abdominal cavity at the beginning, 4 and 7 days after administration of pyridoxamine.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pyridoxamine (200 mg) is orally administered at 3 times daily for 7 days.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key 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.
Key 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.
Target sample size	6

Research contact person
Name of lead principal investigator	Masaaki Nakayama
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1217
Email	masanaka@fmu.ac.jp

Public contact
Name of contact person	Masaaki Nakayama
Organization	Fukushima Medical University
Division name	Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Address	1 Hikarigaoka, Fukushima, Japan
TEL	024-547-1217
Homepage URL
Email	masanaka@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 08 Day
Anticipated trial start date	2016 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 09 Day
Last modified on	2017 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024179