UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010962 |
|---|---|
| Receipt number | R000012829 |
| Scientific Title | Clinical effect of intravenous carnitine supplementation and the change of blood carnitine levels in hemodialysis patients:an observational study |
| Date of disclosure of the study information | 2013/06/14 |
| Last modified on | 2018/05/08 23:28:01 |
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Basic information
Public title
Clinical effect of intravenous carnitine supplementation and the change of blood carnitine levels in hemodialysis patients:an observational study
Acronym
Effect of intravenous carnitine supplementation in hemodialysis patients
Scientific Title
Clinical effect of intravenous carnitine supplementation and the change of blood carnitine levels in hemodialysis patients:an observational study
Scientific Title:Acronym
Effect of intravenous carnitine supplementation in hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood carnitine levels before and after intravenous carnitine injection.
To observe the effect of intravenous carnitine supplementation such as the improvement of renal anemia, and decrease of cardiovascular events, cramps, and disdialysis syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of blood carnitine levels before and after intravenous carnitine injection.
Key secondary outcomes
Improvement of renal anemia, decrease of cardiovascular events, cramps, and disdialysis syndrome.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients who receive intravenous carnitine supplementation.
Key exclusion criteria
Patients who reject to enter this study
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeto Oda |
Organization
Chiba University, Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
1-8-1 Inohana, Chuoh-ku, Chiba city, Chiba 260-8677, Japan.
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Hattori |
Organization
Chiba University, Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
TEL
Homepage URL
hat@shogo.com
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Chiba University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Emergency and Critical Care Medicine, Chiba University, Graduate School of Medicine
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 | 06 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No data are available now.
Management information
Registered date
| 2013 | Year | 06 | Month | 14 | Day |
Last modified on
| 2018 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012829
