UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039353 |
|---|---|
| Receipt number | R000044865 |
| Scientific Title | Effect of once, twice, or thrice weekly administration of intravenous levocarnitine in the treatment of patients with carnitine deficiency undergoing hemodialysis: a retrospective observational study. |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2020/03/09 18:08:48 |
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Basic information
Public title
Effect of once, twice, or thrice weekly administration of intravenous levocarnitine in the treatment of patients with carnitine deficiency undergoing hemodialysis: a retrospective observational study.
Acronym
Effect of levocarnitine on hemodialysis
Scientific Title
Effect of once, twice, or thrice weekly administration of intravenous levocarnitine in the treatment of patients with carnitine deficiency undergoing hemodialysis: a retrospective observational study.
Scientific Title:Acronym
Effect of levocarnitine on hemodialysis
Region
| Japan |
Condition
Condition
patients with carnitine deficiency undergoing hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate the usefulness of intravenous (IV) levocarnitine administration in patients with carnitine deficiency undergoing hemodialysis (HD). We compared the effects of IV-levocarnitine administration at various doses in the treatment of HD patients with renal anemia, hypotension, cardiac insufficiency, and muscle weakness. Levocarnitine, in oral and injected formulations, has been reported to reduce the required dose of erythropoiesis-stimulating agents (ESA) in HD treatment. However, the optimal frequency of levocarnitine administration required for this effect remains unclear. We compared the effects of levocarnitine administration at several frequencies in the treatment of carnitine-deficiency patients with renal anemia undergoing HD, through the measurement of total carnitine (TC) and free carnitine (FC) serum levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
renal anemia
Key secondary outcomes
total carnitine, free carnitine serum levels,hypotension, cardiac insufficiency, and muscle weakness. the required ESA
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We compared the effects of levocarnitine administration at several frequencies in the treatment of carnitine-deficiency patients with renal anemia undergoing HD, through the measurement of total carnitine (TC) and free carnitine (FC) serum levels.
Key exclusion criteria
The study excluded patients who (1) had previously received oral or IV levocarnitine; (2) had received any carnitine supplement; (3) had difficulty communicating due to dementia or other factors; (4) had acute inflammation; (5) had received immunosuppressants, steroids, or antibiotics; and (6) had received blood transfusion in the past 6 months.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Sawada |
Organization
Ijinkai General Takeda Hospital,
Division name
Division of Nephrology & Hemodialysis, Hemodialysis Center,
Zip code
6191495
Address
28-1, Ishidamoriminami-machi, Hushimi-ku, Kyoto City, Kyoto Prefecture; 601-1495, Japan
TEL
075-572-6331
shoheisawada@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Sawada |
Organization
Ijinkai General Takeda Hospital,
Division name
Division of Nephrology & Hemodialysis, Hemodialysis Center,
Zip code
6191495
Address
28-1, Ishidamoriminami-machi, Hushimi-ku, Kyoto City, Kyoto Prefecture; 601-1495, Japan
TEL
075-572-6331
Homepage URL
shoheisawada@yahoo.co.jp
Sponsor or person
Institute
Division of Nephrology & Hemodialysis, Hemodialysis Center, Ijinkai General Takeda Hospital,
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology & Hemodialysis, Hemodialysis Center, Ijinkai General Takeda Hospital,
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
Ijinkai General Takeda Hospital,
Address
28-1, Ishidamoriminami-machi, Hushimi-ku, Kyoto City, Kyoto Prefecture; 601-1495, Japan
Tel
075-572-6331
shoheisawada@yahoo.co.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
医仁会武田総合病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2020 | 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
101
Results
Total 101 patients. TC and FC before levocarnitine(LC) were 33 and 21 microM/L. 85 had carnitine deficiency. After thrice weekly LC, TC and FC increased to 372 and 228. Treatment also led to a 40% reduction in ESA and decreased intradialytic muscle cramp score. After twice weekly LC, TC and FC increased to 314 and 202, whereas, after once weekly LC, TC and FC increased to 150 and 97. The effect of once-, twice-, or thrice weekly LC on the required ESA dosage continued for 24 weeks.
Results date posted
| 2020 | Year | 02 | Month | 01 | Day |
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
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 09 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 09 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 09 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 10 | Day |
Other
Other related information
retrospective observational study
Management information
Registered date
| 2020 | Year | 02 | Month | 01 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044865
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/03/09 | エルカルチン実施計画書_Ver1.0_FIX.pdf |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
