UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007169 |
|---|---|
| Receipt number | R000008434 |
| Scientific Title | Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2015/01/31 11:06:25 |
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Basic information
Public title
Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis
Acronym
Pharmacokinetics of pyridoxiamine
Scientific Title
Pharmacokinetics test of pyridoxamine in uremic patients on peritoneal dialysis
Scientific Title:Acronym
Pharmacokinetics of pyridoxiamine
Region
| Japan |
Condition
Condition
End-stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine pharmacokinetics of oral pyridoxiamine in patients on peritoneal dialysis
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of oral pyridoxiamine
Key secondary outcomes
Changes in carbonyl stress in the abdominal cavity and blood
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
Oral pyridoxiamine 300-600 mg
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
Receiving maintenance peritoneal dialysis at least for 3 months
Not reiving vitamin B6 in the last 4 weeks
Key exclusion criteria
Receiving hemodialysis in addition to peritoneal dialysis
Severe liver disease or liver dysfunction
History of allergy or adverse effects to certain drugs
Participating in other clinical trials or received investigational products in the last 16 weeks
Having active cancers or received complete resection of cancers in the last 3 years
History of cardiovascular disease in the last 6 months
Receiving peritoneal dialysis for more than 8 years or having suspected encapsulating peritoneal sclerosis
Fontaine stage II peripheral arterial disease
Treatment resistant hypertension
Treatment resistant diabetes
Erythropoietin resistant anemia
Received aminophylline, theophylline, choline theophylline, or levodopa in the last 4 weeks
Pregnant women or those intending to become pregnant during the next 1 year
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
kakuta@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
143 Shimo-Kasuya, Isehara, 259-1193, Japan
TEL
0463-93-1121
Homepage URL
kakuta@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Health and Labour Sciences Research Grant on Intractable Diseases
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
| 2012 | Year | 02 | Month | 01 | 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
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | 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
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008434
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
