UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015185
Receipt number R000017657
Scientific Title Clinical efficacy of levocarnitine supplementation in patients with hemodialysis
Date of disclosure of the study information 2014/09/17
Last modified on 2018/04/06 20:21:59

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Basic information

Public title

Clinical efficacy of levocarnitine supplementation in patients with hemodialysis

Acronym

Levocarnitine on hemodialysis patients

Scientific Title

Clinical efficacy of levocarnitine supplementation in patients with hemodialysis

Scientific Title:Acronym

Levocarnitine on hemodialysis patients

Region

Japan


Condition

Condition

Hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the clinical effects of L-carnitine supplementation on patients with hemodialysis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

cardiac function, renal anemia, atherosclerosis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Levocarnitine injection 1000mg 3times weekly

Interventions/Control_2

Control

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)Plasma free carnitine concentration less than 40 micro mol/L
2)duration of dialysis >12 months at enrollment
2)Patients who are treated with hemodialysis three times per week

Key exclusion criteria

(1) history of amputation of extremities or the presence of peripheral arterial disease; (2) a history of severe heart failure, angina, myocardial infarction, or stroke within the past 6 months; (3) the presence of infectious disease, thyroid disease, malignant tumors, or treatment with steroids or immunosuppressants; and (4) L-carnitine supplementation within the past 6 months.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Terumi Higuchi

Organization

Keiai Hospital

Division name

Department of Nephrology

Zip code


Address

3-10-23, Mukaihara, Itabashi-ku, Tokyo, Japan

TEL

+81-3-3973-3811

Email

thiguchi@keiai-hospital.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masanori Abe

Organization

Nihon University School of Medicine

Division name

Department of Nephrology, Hypertension, and Endocrinology

Zip code


Address

30-1, Oyaguchi Kami-chou, Itabashi-ku, Tokyo, Japan

TEL

+81-3-3972-8111

Homepage URL


Email

abe.masanori@nihon-u.ac.jp


Sponsor or person

Institute

Keiai Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Meirikai Chuo General Hospital

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

2014 Year 09 Month 17 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 07 Month 01 Day

Last follow-up date

2015 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 17 Day

Last modified on

2018 Year 04 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name