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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020956
Receipt No. R000024179
Scientific Title Evaluation of effect of pyridoxamine on reducing carbonyl stress in patients receiving peritoneal dialysis. -Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis -
Date of disclosure of the study information 2016/02/09
Last modified on 2017/02/09

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Basic information
Public title Evaluation of effect of pyridoxamine on reducing carbonyl stress in patients receiving peritoneal dialysis.
-Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis -
Acronym Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis.
Scientific Title Evaluation of effect of pyridoxamine on reducing carbonyl stress in patients receiving peritoneal dialysis.
-Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis -
Scientific Title:Acronym 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
1st name
Middle name
Last name Masaaki Nakayama
Organization Fukushima Medical University
Division name Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Zip code
Address 1 Hikarigaoka, Fukushima, Japan
TEL 024-547-1217
Email masanaka@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Nakayama
Organization Fukushima Medical University
Division name Department of Nephrology, Hypertension, Diabetology, Endocrinology and Metabolism
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 12 Month 08 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000024179

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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