UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients.
Title of the study (Brief title)	Investigation of the efficacy of the supplement of L-carnitine for the hemodialysis patients.
Region	Japan

Condition
Condition	hemodialysis patients with chronic renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation the improvement of various symptoms, clinical data and QOL by supplementing the L-carnitine for hemodialysis patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	#1 questionnaire survey(pysical weariness, muscle condition, et al.) #2 regular blood test and chest X-ray #3 test of physical strength #4 muscle mass #5 ERI(erythropoietin resistance index) #6 differential count of carnitine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1: actual drug giving L-carnitine (20mg/kg/dialysis) over 6 months then, 2:placebo giving saline (5ml/dialysis) over 6 months
Interventions/Control_2	1:pacebo giving saline (5ml/dialysis) over 6 months then, 2:actual drug giving L-carnitine (20mg/kg/dialysis) over 6 months
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1: Patients undergo hemodialysis for more than one year. 2: Patients didn't recieve the carnitine drugs for 6 months before this trial. 3: Petients participate in this trial on their own will.
Key exclusion criteria	1: carnitine allergy 2: pregnant women
Target sample size	100

Research contact person
Name of lead principal investigator	Yoshiyuki Toya
Organization	Yokohama City University Hospital
Division name	Blood Purification Center
Address	3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL	045-787-2511
Email	ystoya@yokohama-cu.ac.jp

Public contact
Name of contact person	KeisukeYatsu
Organization	Yokohama City University Graduate School of Medicine
Division name	Medical Science and Cardiorenal Medicine
Address	3-9, Fukuura, Kanazawa-ku, Yokohama City
TEL	045-787-2511
Homepage URL
Email	k-yatsu@be.wakwak.com

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 02 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 01 Month 09 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 01 Month 29 Day
Last modified on	2017 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015188