UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence rate of carnitine and zinc deficiency and the efficacy of levocarnitine injection therapy in dialysis patients with renal anemia
Acronym	Effivavy of levocarnitine in patients with anemia
Scientific Title	Efficacy and safety of levocarnitine injection therapy in dialysis patients with renal anemia
Scientific Title:Acronym	Effivavy of levocarnitine in patients with anemia
Region	Japan

Condition
Condition	End-stage kidney disease undergoing hemodialysis or peritoneal dialysis with renal anemia.
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the prevalence rate of carnitine deficiency and the efficacy of levocarnitine for dialysis patients. Furthermore, we investigate the association with anemia-related factors, such as iron and zinc.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of carnitine deficincy, Physical function, lean body mass, BMI
Key secondary outcomes	Erythropoietin responsiveness index, Dose of erythropiesis stimulating agents, Hemoglobin, and zinc level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	1,000 mg dose of levocarnitine by injection three times a week after hemodialysis
Interventions/Control_2	Control (no levocarnitine therapy)
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) who received hemodialysis or peritoneal dialysis in our hospitals, (2) whose medical decisions were made at our hospitals, and (3) who were 20 to 85 years of age.
Key exclusion criteria	(1) patients who had previously taken levocarnitine, either orally or injected; (2) patients who were taking carnitine or zinc preparation as a supplement; (3) patients who have difficulty communicating owing to dementia or other factors; (4) patients with acute inflammation; (5) patients taking an immunosuppressive drug, steroid, or antibiotic; and (6) patients with a history of blood transfusion within the past six months.
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Middle name Last name Terumi Higuchi
Organization	Keiai Hospital
Division name	Nephrology
Zip code
Address	3-10-23, Mukaihara, Itabashi-ku, Tokyo, Japan
TEL	03-3973-8111
Email	thiguchi@keiai-hospital.jp

Public contact
Name of contact person	1st name Middle name Last name Terumi Higuchi
Organization	Keiai Hospital
Division name	Nephrology
Zip code
Address	3-10-23, Mukaihara, Itabashi-ku, Tokyo, Japan
TEL	03-3973-8111
Homepage URL
Email	thiguchi@keiai-hospital.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Nihon 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2016 Year 12 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 19 Day
Last modified on	2020 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029073