UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007874
Receipt number R000009272
Scientific Title Effect of L-Carnitine Supplementation associated with muscle sympton, renal anemia and cardiac function in dialysis patients.
Date of disclosure of the study information 2012/05/14
Last modified on 2016/01/14 14:58:45

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Basic information

Public title

Effect of L-Carnitine Supplementation associated with muscle sympton, renal anemia and cardiac function in dialysis patients.

Acronym

Efffect of L-Carnitine Supplementation in dialysis patients.

Scientific Title

Effect of L-Carnitine Supplementation associated with muscle sympton, renal anemia and cardiac function in dialysis patients.

Scientific Title:Acronym

Efffect of L-Carnitine Supplementation in dialysis patients.

Region

Japan


Condition

Condition

Chronic kidney disease (dialysis patients)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate the effects of L-Carnitine suppklementation associated with muscle sympton, renal anemia and cardiac function in dailysis patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Improvements of muscle sympton, renal anemia and cardiac function.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

L-Carnitine supplemetation in dailysis patients.

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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

To be continued dialysis more than one year.

To be taken ESA continuously or newly.

Key exclusion criteria

allergy of L-Carnitine

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhiko Tomino

Organization

Juntendo University

Division name

Nephrology

Zip code


Address

3-1-3Hongou, Bunkyou-ku, Tokyo

TEL

03-3813-3111

Email

yasu@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroaki Io

Organization

juntendo University

Division name

Nephrology

Zip code


Address

3-1-3Hongou, Bunkyou-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

chiken@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

2012 Year 05 Month 14 Day


Related information

URL releasing protocol


Publication of results

Partially 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

2012 Year 04 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

2014 Year 06 Month 01 Day

Date of closure to data entry

2014 Year 11 Month 04 Day

Date trial data considered complete

2014 Year 11 Month 04 Day

Date analysis concluded

2014 Year 11 Month 04 Day


Other

Other related information



Management information

Registered date

2012 Year 05 Month 01 Day

Last modified on

2016 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name