UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015153 |
|---|---|
| Receipt number | 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 09:41:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ana65641@nifty.com
Sponsor or person
Institute
Fukuoka Dental College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017576
