UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of palatability of newly developed fast disintegrating tablet of Kremezin in patient.
Title of the study (Brief title)	Evaluation of palatability of Kremezin tablet.
Region	Japan

Condition
Condition	Chronic renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To carify the palataboility of fast disintegrating tablet of kremezin.
Basic objectives2	Others
Basic objectives -Others	Adherence of taking medicines.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Palatability of fast disintegrating tablet of kremezin
Key secondary outcomes	Overall adherence for all medicine prescrived. Adherence for Kremezin formulations. Changes of body weight, BUN, s-Cre and eGFR

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	20-80 year-old patients(male and female) Patients who have taken kremezin fine grain at the time of the first questionnaire and have taken medication of it for more than 1 month Patients who give the singed informed consent.
Key exclusion criteria	Patients who apply to administration contraindications in the package insert of kremezin Patients who will not see the outpatients clinic within 2 weeks to 2 months Patients who can not communicate due to cognitive deterioration Patients who do not manage medication by themselves and their families Patients who it is hard to swallow Patients who have extraordinary state in oral cavity. Patients who is considered as imappropriate by doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	Namiki Noriyuki
Organization	School of Pharmaceutical Sciences University of Shizuoka
Division name	Department of Pharmaceutical Science
Address	52-1, Yada, Suruga, Shizuoka
TEL	054-264-5237
Email	namiki@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	Uchida Shinya
Organization	School of Pharmaceutical Sciences University of Shizuoka
Division name	Department of Pharmaceutical Science
Address	52-1, Yada, Suruga, Shizuoka
TEL	054-264-5234
Homepage URL
Email	uchidas@u-shizuoka-ken.ac.jp

Sponsor
Institute	School of Pharmaceutical Sciences University of Shizuoka
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	医療法人 優雅 東林間かねしろ内科クリニック 医療法人 優雅 鶴間かねしろ内科クリニック

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 29 Day
Anticipated trial start date	2018 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Questionnaire survey (palatability and adhereance) are perfomed to patients who are prescrived fast disintegrating tablets of Kremnezin changed from the fine granule formulation. After 14 days to 2 months, same questionnaire survey (palatability and adhereance) will be perfomed.

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2019 Year 02 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035712