UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026667 |
|---|---|
| Receipt number | R000030626 |
| Scientific Title | the effect on intestinal microbiota with Sucroferric oxyhydroxide |
| Date of disclosure of the study information | 2017/03/23 |
| Last modified on | 2017/03/23 17:57:56 |
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Basic information
Public title
the effect on intestinal microbiota with Sucroferric oxyhydroxide
Acronym
the effect on intestinal microbiota with Sucroferric oxyhydroxide
Scientific Title
the effect on intestinal microbiota with Sucroferric oxyhydroxide
Scientific Title:Acronym
the effect on intestinal microbiota with Sucroferric oxyhydroxide
Region
| Japan |
Condition
Condition
chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we analyze the change of intestinal microbiota of hemodialysis patients with Sucroferric oxyhydroxide, and the change of uremic toxin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intestinal microbiota and uremic toxin of hemodialysis patients before and after treatment with Sucroferric oxyhydroxide
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
treatment with Sucroferric oxyhydroxide
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hyperphosphatemic pahtiets on hemodialysis
Key exclusion criteria
the patients with anti-biotic agents
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Iguchi |
Organization
Nagaoka red cross hospital
Division name
Division of Clinical Nephrology and Rheumatology
Zip code
Address
2-297-1, Senshu, Nagaoka, Niigata
TEL
0258-28-3600
igucci4444@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Iguchi |
Organization
Nagaoka red cross hospital
Division name
Division of ClinicaNephrology and Rheumatology
Zip code
Address
2-297-1 Senshu, Nagaoka, Niigata
TEL
0258-28-3600
Homepage URL
igucci4444@yahoo.co.jp
Sponsor or person
Institute
Nagaoka red cross hospital
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030626
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
