UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009501 |
|---|---|
| Receipt number | R000011162 |
| Scientific Title | impact of Indoxyl Sulfate on prognosis following PCI in patients with CKD |
| Date of disclosure of the study information | 2012/12/07 |
| Last modified on | 2021/06/15 15:29:21 |
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Basic information
Public title
impact of Indoxyl Sulfate on prognosis following PCI in patients with CKD
Acronym
IS-PCI
Scientific Title
impact of Indoxyl Sulfate on prognosis following PCI in patients with CKD
Scientific Title:Acronym
IS-PCI
Region
| Japan |
Condition
Condition
coronary heart disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of Indoxyl Sulfate on clincal outcome at one month and one year in patiennts on chronic kidney disease who undergo PCI
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiovasculr event at one year
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients on chronic kidney disease (eGFR<60) who under go PCI
2) Patient who give informed consent
Key exclusion criteria
Patients whom investigater/phisicians consider to be inappropriat to participae in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 1) Kengo Tanabe 2) Masayuki Yoshida |
Organization
1) Mitsui Memorial Hospital
2) Tokyo Medical and Dental University
Division name
1)Division of Cardiology 2)Life Science and Bioethics Research Center
Zip code
Address
Kandaizumi-chyo 1, Chiyoda-ku, Tokyo
TEL
03-3862-9111
kengo-t@zd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Tanabe |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
Address
Kanda-izumicyo 1, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
kengo-t@zd5.so-net.ne.jp
Sponsor or person
Institute
Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Tanabe-Mitsubishi
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 12 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will take blood samples in patient wth chronic kidney disease who undergo PCI. We will investigate the impact of indoxyl sulfate on clnical outcome.
Management information
Registered date
| 2012 | Year | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011162
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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