UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between anemia and small bowel lesion in dialysis patients
Acronym	Relationship between anemia and small bowel lesion in dialysis patients
Scientific Title	Relationship between anemia and small bowel lesion in dialysis patients
Scientific Title:Acronym	Relationship between anemia and small bowel lesion in dialysis patients
Region	Japan

Condition
Condition	small intestinal lesion
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the cause of unexplained anemia in dialysis patients
Basic objectives2	Others
Basic objectives -Others	Scrutiny of small bowel lesions in dialysis patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between anemia and small bowel lesion
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	small intestinal capsule endoscopy
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	1) Patients who have oral and written informed consent. 2) Patients who are planning to introduce or introduce hemodialysis therapy. 3) Gender and age are irrelevant.
Key exclusion criteria	1) Patients with swallowing disorder. 2) Patients with a very poor general condition. 3) Patients who can not confirm patency of the gastrointestinal tract. 4) A patient who is implanting a cardiac pacemaker or other medical electronic device in the body. 5) A patient who can not obtain consent for removal by endoscopic or surgical operation when the capsule endoscope stays. 6) Patients participating in other studies or clinical trials that directly or indirectly affect the results of this study. 7) Patient judged unsuitable as a subject by research researcher or research sharing doctor.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kazuhide Middle name Last name Higuchi
Organization	Osaka Medical College
Division name	Second department of internal medicine
Zip code	569-8686
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Email	higuchi@osaka-med.ac.jp

Public contact
Name of contact person	1st name Kazuhiro Middle name Last name Ota
Organization	Osaka medical college
Division name	Second department of internal medicine
Zip code	569-8686
Address	2-7, Daigaku-machi, Takatsuki
TEL	072-683-1221
Homepage URL
Email	clash_kaz@yathoo.co.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethic review committee at Ishikiri seiki Hospital
Address	18-28, Yayoi-machi, Higashi-Osaka
Tel	072-988-3121
Email	clash_kaz@yahop.co.jp

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	2019 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	39
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	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Date of IRB	2019 Year 01 Month 21 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2019 Year 12 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 08 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040810