UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012222 |
|---|---|
| Receipt number | R000014289 |
| Scientific Title | The usefulness of L-carnitine supplementation in hemodialysis patients |
| Date of disclosure of the study information | 2013/11/06 |
| Last modified on | 2013/11/05 20:14:09 |
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Basic information
Public title
The usefulness of L-carnitine supplementation in hemodialysis patients
Acronym
The usefulness of L-carnitine supplementation in hemodialysis patients
Scientific Title
The usefulness of L-carnitine supplementation in hemodialysis patients
Scientific Title:Acronym
The usefulness of L-carnitine supplementation in hemodialysis patients
Region
| Japan |
Condition
Condition
hemodialysis patients (chronic kidney disease)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of L-carnitine supplementation on cardiac function, anemia and exercise tolerance in hemodialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of cardiac function, anemia and exercise tolerance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(1) Intravenous L-carnitine 20 mg/kg administration after each hemodialysis for 6 months
(2) Wash out for 3months
(3) Intravenous saline administration after each hemodialysis for 6months
Interventions/Control_2
(1) Intravenous saline administration after each hemodialysis for 6months
(2) Wash out for 3months
(3) Intravenous L-carnitine 20 mg/kg administration after each hemodialysis for 6 months
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemodialisys patients
Key exclusion criteria
Patients known to have a history of complication or allergy to L-carnitine.
Women who are pregnant or possibly pregnant.
Patients who are judged to be inappropriate to this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiharu Kokuho |
Organization
Yokosuka city hospital
Division name
Department of nephrology
Zip code
Address
1-3-2, Nagasaka, Yokosuka, Kanagawa
TEL
046-856-3136
yusuke.kob@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Kobayashi |
Organization
Yokosuka city hospital
Division name
Department of nephrology
Zip code
Address
1-3-2, Nagasaka, Yokosuka, Kanagawa
TEL
046-856-3136
Homepage URL
yusuke.kob@live.jp
Sponsor or person
Institute
Yokosuka city hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | 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
| 2013 | Year | 11 | Month | 06 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014289
