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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025327
Receipt No. R000029073
Scientific Title Efficacy and safety of levocarnitine injection therapy in hemodialysis patients with renal anemia
Date of disclosure of the study information 2016/12/19
Last modified on 2018/04/06

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Basic information
Public title Efficacy and safety of levocarnitine injection therapy in hemodialysis patients with renal anemia
Acronym Effivavy of levocarnitine in patients with anemia
Scientific Title Efficacy and safety of levocarnitine injection therapy in hemodialysis patients with renal anemia
Scientific Title:Acronym Effivavy of levocarnitine in patients with anemia
Region
Japan

Condition
Condition End-stage kidney disease on hemodialysis, renal anemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of levocarnitine injection for hemodialysis patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Physical function, lean body mass, BMI
Key secondary outcomes Erythropoietin responsiveness index, Dose of erythropiesis stimulating agents, Hemoglobin 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 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 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 60

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
2018 Year 04 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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