UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical effect of intravenous carnitine supplementation and the change of blood carnitine levels in hemodialysis patients:an observational study
Title of the study (Brief title)	Effect of intravenous carnitine supplementation in hemodialysis patients
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure blood carnitine levels before and after intravenous carnitine injection. To observe the effect of intravenous carnitine supplementation such as the improvement of renal anemia, and decrease of cardiovascular events, cramps, and disdialysis syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of blood carnitine levels before and after intravenous carnitine injection.
Key secondary outcomes	Improvement of renal anemia, decrease of cardiovascular events, cramps, and disdialysis syndrome.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Hemodialysis patients who receive intravenous carnitine supplementation.
Key exclusion criteria	Patients who reject to enter this study
Target sample size	11

Research contact person
Name of lead principal investigator	Shigeto Oda
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
Address	1-8-1 Inohana, Chuoh-ku, Chiba city, Chiba 260-8677, Japan.
TEL
Email

Public contact
Name of contact person	Noriyuki Hattori
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
Address
TEL
Homepage URL
Email	hat@shogo.com

Sponsor
Institute	Department of Emergency and Critical Care Medicine, Chiba University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Emergency and Critical Care Medicine, Chiba University, Graduate 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

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 06 Month 12 Day
Anticipated trial start date	2013 Year 06 Month 17 Day
Last follow-up date	2015 Year 03 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	No data are available now.

Management information
Registered date	2013 Year 06 Month 14 Day
Last modified on	2018 Year 05 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012829