UMIN-CTR Clinical Trial

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

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

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

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