UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of influence of changing dialysate calcium concentration on bone mineral metabolism, nutritional status and prognosis in hemodialysis patients
Title of the study (Brief title)	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	Hiroki Niwa
Organization	Iwata city Hospital
Division name	Renal Division
Address	512-3 Ohkubo, Iwata, Shizuoka
TEL	0538-38-5000
Email	niwahiroki77@gmail.com

Public contact
Name of contact person	Hiroki Niwa
Organization	Iwata City Hospital
Division name	Renal Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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