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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039353
Receipt No. 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

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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
Email 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
Email shoheisawada@yahoo.co.jp

Sponsor
Institute Division of Nephrology & Hemodialysis, Hemodialysis Center, Ijinkai General Takeda Hospital,
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name

Research case data
Registered date File name


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