UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035821 |
|---|---|
| Receipt number | R000040810 |
| Scientific Title | Relationship between anemia and small bowel lesion in dialysis patients |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2019/12/03 18:50:10 |
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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
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
clash_kaz@yathoo.co.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040810
