UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035143 |
|---|---|
| Receipt number | R000040056 |
| Scientific Title | Investigation of efficacy of levocarnitine intravenous formulation in patients undergoing hemodialysis |
| Date of disclosure of the study information | 2018/12/10 |
| Last modified on | 2019/12/06 11:17:51 |
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Basic information
Public title
Investigation of efficacy of levocarnitine intravenous formulation in patients undergoing hemodialysis
Acronym
Levocarnitine study
Scientific Title
Investigation of efficacy of levocarnitine intravenous formulation in patients undergoing hemodialysis
Scientific Title:Acronym
Levocarnitine study
Region
| Japan |
Condition
Condition
hemodialysis patients with cardiac dysfunction
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of efficacy of intravenous administration of levocarnitine in patients undergoing hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of cardiac function by echocardiography, before, 3, 6, 12 months after administration.
Evaluation item: LVMI, LVEF, LVFS, E/A, e', E/e', LAVI
Key secondary outcomes
Carnitine concentration in blood
symptoms
side effect
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
hemodialysis patients with cardiac dysfunction
Key exclusion criteria
doctor's judgement,
patient who did not agree with the investigation
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Minatoguchi |
Organization
Gifu University
Division name
Department of Circulatory and Respiratory Advanced MedicineGraduate School of Medicine,
Zip code
501-1101
Address
Yanagido 1-1, Gifu city, Gifu Prefecture
TEL
0582306523
minatos@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Minatoguchi |
Organization
Gifu University
Division name
Department of Circulatory and Respiratory Advanced Medicine, Graduate School of Medicine
Zip code
5011194
Address
Yanagido 1-1, Gifu city, Gifu Prefecture
TEL
058-230-6523
Homepage URL
minatos@gifu-u.ac.jp
Sponsor or person
Institute
Ministry of Education, Culture, Sports, Science and Technology
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
Gifu University
Address
Yanagido 1-1
Tel
0582306000
minatos@gifu-u.ac.jp
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
| 2018 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
96
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
| 2018 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not particular
Management information
Registered date
| 2018 | Year | 12 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040056
