UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008585 |
|---|---|
| Receipt number | R000010085 |
| Scientific Title | A pilot study to evaluate the efficacy of 3 doses of L-carnitine supplementation in chronic kidney disease patients with complications caused by carnitine deficiency |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/08/01 13:33:33 |
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Basic information
Public title
A pilot study to evaluate the efficacy of 3 doses of L-carnitine supplementation in chronic kidney disease patients with complications caused by carnitine deficiency
Acronym
"CENTRAL"
Scientific Title
A pilot study to evaluate the efficacy of 3 doses of L-carnitine supplementation in chronic kidney disease patients with complications caused by carnitine deficiency
Scientific Title:Acronym
"CENTRAL"
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of symptoms due to carnitine deficiency (muscle cramps, fatigue and anemia)
Key secondary outcomes
reduction of the dose of ESA, improvement of anemia, frequency of administration of shakuyakukanzoto, change in muscle mass, improvement of cardiac function, adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-carnitine 300mg
Interventions/Control_2
L-carnitine 600mg
Interventions/Control_3
L-carnitine 1200mg
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
1)patients who are thought to be deficient of carnitine
2)patients who have more than 2 symptoms as belows:
.renal anemia regardless of ESA
.muscle cramps
.fatigue
.arrhythmia
.cardiac hypertrophy
3)no limitation of age and sex
4)ability to provide written informed consent
Key exclusion criteria
1)history of allergy against this drug
2)ability of oral administration
3)alcoholic or drug abuse
4)cancer
5)patients who are judged to be inappropriate to this study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taichi Nakamura |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Internal Medicine, Nephrology
Zip code
Address
3-12-1 Shinyamashita Naka-ku Yokohama Kanagawa
TEL
045-628-6100
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taichi Nakamura |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Internal Medicine, Nephrology
Zip code
Address
3-12-1 Shinyamashita Naka-ku Yokohama Kanagawa
TEL
045-628-6100
Homepage URL
Sponsor or person
Institute
Yokohama City Minato Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2012 | Year | 07 | Month | 31 | Day |
Last modified on
| 2012 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010085
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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