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Recruitment status Completed
Unique ID issued by UMIN UMIN000015185
Receipt No. R000017657
Official scientific title of the study Clinical efficacy of levocarnitine supplementation in patients with hemodialysis
Date of disclosure of the study information 2014/09/17
Last modified on 2018/04/06

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Basic information
Official scientific title of the study Clinical efficacy of levocarnitine supplementation in patients with hemodialysis
Title of the study (Brief title) Levocarnitine on hemodialysis patients
Region
Japan

Condition
Condition Hemodialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical effects of L-carnitine supplementation on patients with hemodialysis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes cardiac function, renal anemia, atherosclerosis
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Levocarnitine injection 1000mg 3times weekly
Interventions/Control_2 Control
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Plasma free carnitine concentration less than 40 micro mol/L
2)duration of dialysis >12 months at enrollment
2)Patients who are treated with hemodialysis three times per week
Key exclusion criteria (1) history of amputation of extremities or the presence of peripheral arterial disease; (2) a history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months; (3) the presence of infectious disease, thyroid disease, malignant tumors, or treatment with steroids or immunosuppressants; and (4) L-carnitine supplementation within the past 6 months.
Target sample size 100

Research contact person
Name of lead principal investigator Terumi Higuchi
Organization Keiai Hospital
Division name Department of Nephrology
Address 3-10-23, Mukaihara, Itabashi-ku, Tokyo, Japan
TEL +81-3-3973-3811
Email thiguchi@keiai-hospital.jp

Public contact
Name of contact person Masanori Abe
Organization Nihon University School of Medicine
Division name Department of Nephrology, Hypertension, and Endocrinology
Address 30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, Japan
TEL +81-3-3972-8111
Homepage URL
Email abe.masanori@nihon-u.ac.jp

Sponsor
Institute Keiai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Meirikai Chuo General Hospital
Name of secondary funder(s)

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
2014 Year 09 Month 17 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 06 Month 01 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Published
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 09 Month 17 Day
Last modified on
2018 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017657


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