UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007650 |
|---|---|
| Receipt number | R000009020 |
| Scientific Title | Efficacy of levocarnitine chloride for myocardial fatty acid metabolism in dialysis patients |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/04/03 02:21:58 |
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Basic information
Public title
Efficacy of levocarnitine chloride for myocardial fatty acid metabolism in dialysis patients
Acronym
levocarnitine chloride and myocardial fatty acid metabolism
Scientific Title
Efficacy of levocarnitine chloride for myocardial fatty acid metabolism in dialysis patients
Scientific Title:Acronym
levocarnitine chloride and myocardial fatty acid metabolism
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the biomarkers concerning about administration of levocarnitine chloride and myocardial fatty acid metabolism
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Serum Asymmeteric dimethylarginen (ADMA)
2.Serum Fatty acid bindingprotein (FABP)3,4 and 5
Key secondary outcomes
1.Serum Acyl carnitine and Free carnitine
2.Plasma Brain natriuretic peptide
3.Serum Cardiac Troponin T
4.Echocardiography
5.Electrocardiogram
6.Cardiothoracic ratio in chest X ray photograph
7.Erithropoietic resistance index
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
levocarnitine chloride oral administration
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.hemodialysis duration is more than 12 months
2.patients who need erythropoiesis stimulating agents (ESA), more than Darbepoetin alfa 15 or epoetin beta 3000 per week
3.patients who gave written informed consent prior to enrollment
Key exclusion criteria
1.patients with a histry of oral levocarnitine chloride including carnitine supplements on the market
2.female patients who are pregnant, nursing or suspected of pregnancy
3.unsuitable patients
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | N Toshima-Minemura |
Organization
Seseragi Hospital
Division name
Internal medicine
Zip code
Address
1-1399 Ichiba-chou,Isesaki-shi,Gunma-ken, 379-2211 JAPAN
TEL
0270-63-6363
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | N Toshima-Minemura |
Organization
Seseragi Hospital
Division name
Internal medicine
Zip code
Address
1-1399 Ichiba-chou,Isesaki-shi,Gunma-ken, 379-2211 JAPAN
TEL
0270-63-6363
Homepage URL
toshima-n@seseragi-hosp.jp
Sponsor or person
Institute
1.Seseragi hospital
2.Department of Medicine & Biological Science Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
1.Department of Medicine & Biological Science Gunma University Graduate School of Medicine
2.Seseragi hospital
3.Grant for pathophysiological research conference in chronic kidney disease
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Department of Medicine & Biological Science Gunma University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
JKFB12-29
Org. issuing International ID_1
The Kindney Foundation, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
せせらぎ病院（群馬県）
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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 | 04 | Month | 03 | Day |
Last modified on
| 2012 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
