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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015153
Receipt No. R000017576
Scientific Title The effect of conversion of dialysate calcium concentration from 3.0 mEq/L to 2.5 mEq/L on mineral and bone disorder in chronic hemodialysis patients
Date of disclosure of the study information 2014/09/15
Last modified on 2015/03/11

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Basic information
Public title The effect of conversion of dialysate calcium concentration from 3.0 mEq/L to 2.5 mEq/L on mineral and bone disorder in chronic hemodialysis patients
Acronym The effect of dialysate calcium concentration on mineral and bone disorder
Scientific Title The effect of conversion of dialysate calcium concentration from 3.0 mEq/L to 2.5 mEq/L on mineral and bone disorder in chronic hemodialysis patients
Scientific Title:Acronym The effect of dialysate calcium concentration on mineral and bone disorder
Region
Japan

Condition
Condition Chronic kidney disease-Mineral and Bone Disorder
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of conversion of dialysate calcium concentration from 3.0 mEq/L to 2.75 mEq/L on mineral and bone disorder in patients undergoing maintenance hemodialysis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Serum levels of phosphate, calcium, and parathyroid hormone
Key secondary outcomes Changes in prescription pattern and achivement rate of JSDT guideline 2012

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 Patients who received maintenace hemodialysis therapy at Fukuoka Renal Clinic on December 1st 2012
Key exclusion criteria Patients who received hemodialysis therapy more than one month at other dialysis facilities between December 1st 2012 to December 1st 2013
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Yamada
Organization Fukuoka Dental College
Division name Kidney Care Unit
Zip code
Address Tamura2-15-1, Sawara-Ku, Fukuoka
TEL 092-801-0411
Email ana65641@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Yamada
Organization Fukuoka Dental College
Division name Department of Internal Medicine
Zip code
Address Tamura2-15-1, Sawara-Ku, Fukuoka
TEL 092-801-0411
Homepage URL
Email ana65641@nifty.com

Sponsor
Institute Fukuoka Dental College
Institute
Department

Funding Source
Organization Fukuoka Dental College
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
2014 Year 09 Month 15 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
2014 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 15 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2015 Year 01 Month 31 Day
Date analysis concluded
2015 Year 02 Month 28 Day

Other
Other related information Unpublished

Management information
Registered date
2014 Year 09 Month 14 Day
Last modified on
2015 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017576

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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