UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025804 |
|---|---|
| Receipt number | R000029654 |
| Scientific Title | Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2017/08/14 17:07:29 |
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Basic information
Public title
Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Acronym
Carnitine Metabolism in Patients on Hemodialysis
Scientific Title
Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Scientific Title:Acronym
Carnitine Metabolism in Patients on Hemodialysis
Region
| Japan |
Condition
Condition
End stage kidney disease on HD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Difference of plasma carnitine levels after at IV infusion and oral carnitine preparation administration and the stopping dosage
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma concentrations of total carnitine(TC),acyl carnitine(AC),free carnitine(FC),and acyl/free carnitine ratio(AC/FC)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Change of dosing route of carnitine from P.O. to IV.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
None
Key exclusion criteria
None
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirokazu Osawa |
Organization
Hakujikai jin clinic
Division name
Dep.of Nephrology
Zip code
Address
5-5-18,Shikahama,Adachi-ku,Tokyo,123-0864
TEL
03-3856-7011
oosawa@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Nakata |
Organization
Hakujikai jin clinic
Division name
Dep.of Nephrology
Zip code
Address
5-5-18,Shikahama,Adachi-ku,Tokyo,123-0864
TEL
03-3856-7011
Homepage URL
jincli@hakujikai.org
Sponsor or person
Institute
Hakujikai jin clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
博慈会腎クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 23 | 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
Plasma concentrations of TC,FC,and AC at the beginning of the study were not statistically different between different dosing amounts although it was higher in the group administered 900mg/day.
TC,FC,AC levels significantly increased after three months upon switching to intravenous administration(TC,FC,AC:p<0.0001),but there was no significant difference in AC/FC during the observation period(p=0.1739).
After discontinuation of carnitine administration,TC,FC,and AC levels before the dialysis significantly decreased over three months,and subsequently decreased slowly after the third month(p<0.0001).The average FC value was maintained at normal levels until nine months,but fell below normal values when measured at the 12th month.
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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 23 | Day |
Last modified on
| 2017 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029654
| 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 |
