UMIN-CTR Clinical Trial

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
Email	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
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	Kitamachi Clinic Ethics Review Committee
Address	1-1-3, Kitamachi, kichijyoji, musasino-city, Tokyo, JAPAN
Tel	070-5011-8550
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039753