UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013009 |
|---|---|
| Receipt number | R000015188 |
| Scientific Title | Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients. |
| Date of disclosure of the study information | 2014/02/01 |
| Last modified on | 2017/08/02 09:30:33 |
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Basic information
Public title
Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients.
Acronym
Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients.
Scientific Title
Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients.
Scientific Title:Acronym
Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients.
Region
| Japan |
Condition
Condition
hemodialysis patients with chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation the improvement of various symptoms, clinical data and QOL by supplementing the L-carnitine for hemodialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
#1 questionnaire survey(pysical weariness, muscle condition, et al.)
#2 regular blood test and chest X-ray
#3 test of physical strength
#4 muscle mass
#5 ERI(erythropoietin resistance index)
#6 differential count of carnitine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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: actual drug
giving L-carnitine (20mg/kg/dialysis) over 6 months
then,
2:placebo
giving saline (5ml/dialysis) over 6 months
Interventions/Control_2
1:pacebo
giving saline (5ml/dialysis) over 6 months
then,
2:actual drug
giving L-carnitine (20mg/kg/dialysis) over 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
1: Patients undergo hemodialysis for more than one year.
2: Patients didn't recieve the carnitine drugs for 6 months before this trial.
3: Petients participate in this trial on their own will.
Key exclusion criteria
1: carnitine allergy
2: pregnant women
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Toya |
Organization
Yokohama City University Hospital
Division name
Blood Purification Center
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2511
ystoya@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KeisukeYatsu |
Organization
Yokohama City University Graduate School of Medicine
Division name
Medical Science and Cardiorenal Medicine
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2511
Homepage URL
k-yatsu@be.wakwak.com
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
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
| 2014 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | 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
| 2014 | Year | 01 | Month | 29 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015188
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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