UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of a Laxative on progression of CKD
Title of the study (Brief title)	J-LUBIC
Region	Japan

Condition
Condition	Chronic Kidney Disease (CKD)
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The study aim is to establish the efficiency of lubiprostone as a novel CKD drug.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	constipation Concentration of uremic toxins Renal funcitons
Key secondary outcomes	gutmicrobiota

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of lubiprostone to CKD patients
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	Not applicable
Gender	Male and Female
Key inclusion criteria	CKD patients with constipation
Key exclusion criteria	ileus
Target sample size	50

Research contact person
Name of lead principal investigator	Takaaki ABE
Organization	Tohoku University Graduate School of Biomedical Engineering
Division name	Division of Medical Science
Address	1-1 Seiryo-cho, Aoba, Sendai,Japan
TEL	022-717-7163
Email	takaabe@med.tohoku.ac.jp

Public contact
Name of contact person	Takaaki ABE
Organization	Tohoku University Graduate School of Biomedical Engineering
Division name	Division of Medical Science
Address	1-1 Seiryo-cho, Aoba, Sendai,Japan
TEL	022-717-7163
Homepage URL
Email	takaabe@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 02 Month 18 Day
Anticipated trial start date	2014 Year 02 Month 18 Day
Last follow-up date	2018 Year 02 Month 28 Day
Date of closure to data entry	2020 Year 02 Month 28 Day
Date trial data considered complete	2020 Year 02 Month 28 Day
Date analysis concluded	2020 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 05 Month 06 Day
Last modified on	2018 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020212