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Recruitment status Completed
Unique ID issued by UMIN UMIN000008636
Receipt No. R000010150
Official scientific title of the study 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

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Basic information
Official scientific title of the study The cross-sectional study which investigates the relationship between serum leptin level and anemia associated with beta2-microglobulin (B2MG) adsorption column in hemodialysis patients.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Ryuichi Furuya
Organization Iwata City Hospital
Division name Renal Division, Department of Internal Medicine
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Email

Public contact
Name of contact person Ryuichi Furuya
Organization Iwata City Hospital
Division name Renal Division, Department of Internal Medicine
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Homepage URL
Email r-furuya@isis.ocn.ne.jp

Sponsor
Institute Iwata City Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010150


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