UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008636
Receipt number R000010150
Scientific Title The cross-sectional study which investigates the relationship between serum leptin level and anemia associated with beta2-microglobulin (B2MG) adsorption column in hemodialysis patients.
Date of disclosure of the study information 2012/08/07
Last modified on 2012/08/07 15:20:51

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Basic information

Public title

The cross-sectional study which investigates the relationship between serum leptin level and anemia associated with beta2-microglobulin (B2MG) adsorption column in hemodialysis patients.

Acronym

The association between leptin and anemia in hemodialysis patients using beta2-microglobulin (B2MG) adsorption column.

Scientific Title

The cross-sectional study which investigates the relationship between serum leptin level and anemia associated with beta2-microglobulin (B2MG) adsorption column in hemodialysis patients.

Scientific Title:Acronym

The association between leptin and anemia in hemodialysis patients using beta2-microglobulin (B2MG) adsorption column.

Region

Japan


Condition

Condition

Chronic renal failure

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to clarify the relationship between serum leptin level and anemia associated with B2MG adsorption column in hemodialysis patients.

Basic objectives2

Others

Basic objectives -Others

To clarify the mechanism

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The relationship between serum leptin level and hemoglobin and/or rHuEPO dose.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

80 years-old >

Gender

Male and Female

Key inclusion criteria

Chronic renal failure on hemodialysis.
Treating with B2MG adsorption column.

Key exclusion criteria

Anemia other than renal anemia.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryuichi Furuya

Organization

Iwata City Hospital

Division name

Renal Division, Department of Internal Medicine

Zip code


Address

512-3 Ohkubo, Iwata, Shizuoka

TEL

0538-38-5000

Email



Public contact

Name of contact person

1st name
Middle name
Last name Ryuichi Furuya

Organization

Iwata City Hospital

Division name

Renal Division, Department of Internal Medicine

Zip code


Address

512-3 Ohkubo, Iwata, Shizuoka

TEL

0538-38-5000

Homepage URL


Email

r-furuya@isis.ocn.ne.jp


Sponsor or person

Institute

Iwata City Hospital

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 08 Month 07 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

Completed

Date of protocol fixation

2012 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 07 Day

Last follow-up date

2012 Year 08 Month 07 Day

Date of closure to data entry

2012 Year 08 Month 07 Day

Date trial data considered complete

2012 Year 08 Month 07 Day

Date analysis concluded

2012 Year 08 Month 07 Day


Other

Other related information

Cross sectional study


Management information

Registered date

2012 Year 08 Month 07 Day

Last modified on

2012 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010150


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name