UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the efficacy of L-carnitine injection in dialysis patients with complications
Title of the study (Brief title)	A study to evaluate the efficacy of L-carnitine injection in dialysis patients with complications
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of L-carnitine injection in dialysis patients with complications.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Usage dose of ESA
Key secondary outcomes	serum carnitine concentration, QOL, muscle symptoms, inflammatory marker, nutritional status, cardiothoracic ratio, adverse events

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	L-carnitine injection 1000mg
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who receive three times a week of hemodialysis more than one year. Patients who has not received carnitine medication for six month before this study. Patients who are under treatment of renal anemia with ESA. Patients who meet the criteria of the carnitine deficiency. Patients providing written informed consent.
Key exclusion criteria	Patients known to have a history or complication of allergy to L-carnitine. Women who are pregnant or possibly pregnant. Patients who are judged to be inappropriate to this study.
Target sample size	100

Research contact person
Name of lead principal investigator	Hidetoshi Ito
Organization	Showa University
Division name	Internal Medicine
Address	35-1 Chigasakichuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
Email

Public contact
Name of contact person
Organization	Showa University
Division name	Internal Medicine
Address	35-1 Chigasakichuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
Homepage URL
Email

Sponsor
Institute	Showa University
Institute
Department

Funding Source
Organization	None
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	2013 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 17 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date
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	2013 Year 07 Month 30 Day
Last modified on	2017 Year 01 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013257