UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012390 |
|---|---|
| Receipt number | R000014488 |
| Scientific Title | Effect of L-Carnitine injection product associated with muscle sympton, renal anemia and cardiac function in dialysis patients. |
| Date of disclosure of the study information | 2013/11/28 |
| Last modified on | 2016/01/14 14:56:09 |
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Basic information
Public title
Effect of L-Carnitine injection product associated with muscle sympton, renal anemia and cardiac function in dialysis patients.
Acronym
Efffect of L-Carnitine injection product in dialysis patients.
Scientific Title
Effect of L-Carnitine injection product associated with muscle sympton, renal anemia and cardiac function in dialysis patients.
Scientific Title:Acronym
Efffect of L-Carnitine injection product in dialysis patients.
Region
| Japan |
Condition
Condition
Chronic kidney disease (hemodialysis patients)
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effects of L-Carnitine injection product associated with muscle sympton, renal anemia and cardiac function in dailysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvements of muscle sympton, renal anemia and cardiac function.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-Carnitine injection product in hemodailysis patients.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
To be continued hemodialysis more than one year.
To be taken ESA continuously or newly
Key exclusion criteria
allergy of L-Carnitine
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University
Division name
Nephrology
Zip code
Address
3-1-3Hongou, Bunkyou-ku, Tokyo
TEL
03-3818-3111
yasu@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Io |
Organization
Juntendo University
Division name
Nephrology
Zip code
Address
3-1-3Hongou, Bunkyou-ku, Tokyo
TEL
03-3813-3111
Homepage URL
chiken@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
順天堂大学附属順天堂医院 腎臓内科
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 28 | 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
| 2013 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 28 | 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
Management information
Registered date
| 2013 | Year | 11 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014488
