UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029383 |
|---|---|
| Receipt number | 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 15:00:33 |
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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
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
niwahiroki77@gmail.com
Sponsor or person
Institute
Iwata City Hospital
Renal Division
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033547
