UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of carnitine on patients receiving hemodialysis
Title of the study (Brief title)	The effect of carnitine on patients receiving hemodialysis
Region	Japan

Condition
Condition	hemodialysis patients claiming muscle relating complaint
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of carnitine on muscular symptom in patients receiving hemodialysis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement of clinical symptom
Key secondary outcomes	serum carnitine concentration

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	administration 900mg of carnitine for 3 months
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	hemodialysis patients claiming muscle symptom
Key exclusion criteria	allergic reaction with carnitine
Target sample size	15

Research contact person
Name of lead principal investigator	Matsuhiko Hayashi
Organization	Keio University, School of medicine
Division name	Apheresis and Dialysis Center
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Email	matuhiko@z3.keio.jp

Public contact
Name of contact person	Yoshihiko KANNO
Organization	School of Medicine, Keio University
Division name	Apheresis and Dialysis Center
Address	35 Shinanomachi, Shinjuku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	kannoyh@tokyo-med.ac.jp

Sponsor
Institute	Apheresis and Dialysis Center, School of medicine, Keio University
Institute
Department

Funding Source
Organization	Keio University, School of medicine
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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 03 Day
Last follow-up date	2013 Year 03 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	2012 Year 04 Month 06 Day
Last modified on	2017 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009050