UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034904 |
|---|---|
| Receipt number | R000039753 |
| Scientific Title | Sucroferric oxyhydroxide Guanules Questionnaire survey |
| Date of disclosure of the study information | 2018/11/20 |
| Last modified on | 2019/11/18 11:10:14 |
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Basic information
Public title
Sucroferric oxyhydroxide Guanules Questionnaire survey
Acronym
Sucroferric oxyhydroxide Guanules Questionnaire survey
Scientific Title
Sucroferric oxyhydroxide Guanules Questionnaire survey
Scientific Title:Acronym
Sucroferric oxyhydroxide Guanules Questionnaire survey
Region
| Japan |
Condition
Condition
Improvement of hyperphosphatemia in dialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Do a survey of Administration feeling of Sucroferric oxyhydroxide Guanules
Basic objectives2
Others
Basic objectives -Others
Administration feeling
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Administration feeling
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
1)Administered Sucroferric oxyhydroxide Guanules and hyperphosphatemia in dialysis patients
2)Patients can acquire written informed consent appropriately (excluding patients with dementia)
Key exclusion criteria
Pharmacist judged ineligible as subject of investigation
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Inami |
Organization
Qol Co.,Ltd.
Division name
Chubu Pharmacy Business Division
Zip code
450-6034
Address
1-1-4, Meieki, Nakamura-ku, Nagoya, Aichi, Japan
TEL
052-589-1389
y-oikawa@apoplus.co.jp
Public contact
Name of contact person
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Oikawa |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Division
Zip code
103-0027
Address
14-1 Nihonbashi2-chome, Chuo-ku, Tokyo, Japan
TEL
03-6386-9500
Homepage URL
y-oikawa@apoplus.co.jp
Sponsor or person
Institute
Qol Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kissei Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitamachi Clinic Ethics Review Committee
Address
1-1-3, Kitamachi, kichijyoji, musasino-city, Tokyo, JAPAN
Tel
070-5011-8550
shingo-namiki@j-smo.com
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
クオール薬局
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.iyaku.info/magazine/magazine_1.html
Number of participants that the trial has enrolled
75
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 11 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 07 | Month | 29 | Day |
Date analysis concluded
| 2019 | Year | 07 | Month | 31 | Day |
Other
Other related information
Questionnaire survey
Management information
Registered date
| 2018 | Year | 11 | Month | 15 | Day |
Last modified on
| 2019 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039753
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
