UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022935 |
|---|---|
| Receipt number | R000026433 |
| Scientific Title | The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities. |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2019/07/01 20:13:16 |
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Basic information
Public title
The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Acronym
The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Scientific Title
The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Scientific Title:Acronym
The usage survey of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Region
| Japan |
Condition
Condition
CKD-MBD in hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To weigh the usage of phosphate binder for CKD-MBD in western Saitama hemodialysis facilities.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The achievement rate of serum phosphate value.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All cases investigation
Key exclusion criteria
Nothing
Target sample size
3600
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
350-0451
Address
38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan
TEL
049-276-1611
hirookda@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Amano |
Organization
Saitama Medical University
Division name
Department of Nephrology
Zip code
350-0451
Address
38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan
TEL
049-276-1611
Homepage URL
hiama@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Saitama Medical University
Address
38 Morohongo, Moroyama-machi, Irumagun Saitama 350-0495, Japan
Tel
049-276-1111
hirb@saitama-med.ac.jp
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
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/30783915
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/30783915
Number of participants that the trial has enrolled
1373
Results
The median serum phosphorus, corrected calcium and intact PTH for April 2015 were 5.4 mg / dL, 9.1 mg / dL and 147 pg / dL, respectively. In addition,more PB types were significantly correlated with higher serum phosphorus levels (p < 0.001). Compared with other agents, significant change was observed only in FeC group, and serum phosphorus decreased by 0.6 mg / dL (N = 39, p = 0.006). Furthermore, in the same group, hemoglobin increased from 10.4 mg / dL to 11.4 mg / dL (p = 0.002).
Results date posted
| 2019 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Hemodialysis patients in dialysis facilities in western Saitama
Participant flow
Of the 54 facilities, 25 facilities participated. 1641 cases were entered, but 1373 cases were finally entered in the test from exclusion criteria.
Adverse events
non
Outcome measures
We evaluated the basic data of western Saitama dialysis patients and compared the changes in serum phosphorus levels when one new phosphate binder was additionally administered.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 06 | Month | 28 | Day |
Last modified on
| 2019 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026433
