UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effect of L-carnitine administration on peritoneal membrane function in peritoneal dialysis patients.
Title of the study (Brief title)	Effect of L- carnitine administration in peritoneal dialysis patients
Region	Japan

Condition
Condition	Secondary carnitine deficiency
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effect of L-carnitine replacement therapy on peritoneal membrane function in peritoneal dialysis patients with secondary carnitine deficiency
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of peritoneal membrane function by administration of L-carnitine
Key secondary outcomes	Residual renal function Cardiac function Erythropoietin resistant anemia Insulin resistance

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Levocarnitine 750mg/day Half a year
Interventions/Control_2	No treatment
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 over the age of 20 years with end stage renal disease undergoing peritoneal dialysis 2.Patients able to provide written informed consent for study participation
Key exclusion criteria	1.Patients under the age of 20 years old 2.Patients who are contraindicated in the package insert of Levocarnitine 3.Patients undergoing combination therapy with peritoneal dialysis and hemodialysis 4.Pregnant woman, or a woman who have possibility of pregnancy 5.Others not inadequate judged by a physician 6.Patients who do not obtain consent
Target sample size	60

Research contact person
Name of lead principal investigator	Kei Fukami
Organization	Kurume University
Division name	Division of Nephrology, Department on Medicine
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL	0942-31-7002
Email	fukami@med.kurume-u.ac.jp

Public contact
Name of contact person	Sakuya Ito
Organization	Kurume University
Division name	Division of Nephrology, Department on Medicine
Address	67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL	0942-31-7763
Homepage URL
Email	itou_sakuya@med.kurume-u.ac.jp

Sponsor
Institute	Division of Nephrology, Department on Medicine, Kurume University
Institute
Department

Funding Source
Organization	Division of Nephrology, Department on Medicine, Kurume University
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	久留米大学病院/Kurume University Hospital

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 27 Day
Anticipated trial start date	2018 Year 02 Month 28 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 28 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035976