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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029383
Receipt No. R000033547
Scientific Title Examination of influence of changing dialysate calcium concentration on bone mineral metabolism, nutritional status and prognosis in hemodialysis patients
Date of disclosure of the study information 2017/10/10
Last modified on 2017/10/02

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Basic information
Public title Examination of influence of changing dialysate calcium concentration on bone mineral metabolism, nutritional status and prognosis in hemodialysis patients
Acronym dialysate calcium concentration and bone mineral metabolism, nutritional status or prognosis
Scientific Title Examination of influence of changing dialysate calcium concentration on bone mineral metabolism, nutritional status and prognosis in hemodialysis patients
Scientific Title:Acronym dialysate calcium concentration and bone mineral metabolism, nutritional status or prognosis
Region
Japan

Condition
Condition chronic kidney disease - mineral and bone disorder
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the influence of changes in dialysate calcium concentration on bone mineral metabolism in hemodialysis patients
Basic objectives2 Others
Basic objectives -Others To clarify the influence of changes in dialysate calcium concentration on nutritional status, and prognosis in hemodialysis patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum Ca, Pi, intact parathyroid hormone levels
Bone metabolism markers
Mortality
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Hemodialysis patient
Key exclusion criteria Under 18 y.o and more than 90 y.o.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Niwa
Organization Iwata city Hospital
Division name Renal Division
Zip code
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Email niwahiroki77@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Niwa
Organization Iwata City Hospital
Division name Renal Division
Zip code
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Homepage URL
Email niwahiroki77@gmail.com

Sponsor
Institute Iwata City Hospital
Renal Division
Institute
Department

Funding Source
Organization Self sourcing
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
2017 Year 10 Month 10 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
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design; Prospective observation test
Subjects; patients undergoing HD in our institution at April 2016
Measurement; TRACP-5b, BAP, intact PTH levels in blood

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2017 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033547

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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