UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034904
Receipt No. R000039753
Scientific Title Sucroferric oxyhydroxide Guanules Questionnaire survey
Date of disclosure of the study information 2018/11/20
Last modified on 2019/08/07

* 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 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
Middle name
Last name Yoshiyuki Inami
Organization Qol Co.,Ltd.
Division name Chubu Pharmacy Business Division
Zip code
Address 1-1-4, Meieki, Nakamura-ku, Nagoya, Aichi, Japan
TEL 052-589-1389
Email y-oikawa@apoplus.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshinobu Oikawa
Organization APO PLUS STATION CO., LTD.
Division name CRO Division
Zip code
Address 14-1 Nihonbashi2-chome, Chuo-ku, Tokyo, Japan
TEL 03-6386-9500
Homepage URL
Email y-oikawa@apoplus.co.jp

Sponsor
Institute Qol Co.,Ltd.
Institute
Department

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
Address
Tel
Email

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 Unpublished

Result
URL related to results and publications
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
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
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 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.