UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020956 |
|---|---|
| Receipt number | 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 17:07:22 |
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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
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
masanaka@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024179
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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