UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035850 |
|---|---|
| Receipt number | R000040837 |
| Scientific Title | Impact of Plasma Indoxyl Sulfate on One-year Adverse Events in Chronic Kidney Disease Patients with Heart Failure: a Prospective, Multicenter Cohort Study |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/08/17 13:51:18 |
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Basic information
Public title
Impact of Plasma Indoxyl Sulfate on One-year Adverse Events in Chronic Kidney Disease Patients with Heart Failure: a Prospective, Multicenter Cohort Study
Acronym
IDSTOP-HF study
Scientific Title
Impact of Plasma Indoxyl Sulfate on One-year Adverse Events in Chronic Kidney Disease Patients with Heart Failure: a Prospective, Multicenter Cohort Study
Scientific Title:Acronym
IDSTOP-HF study
Region
| Japan |
Condition
Condition
Heart failure
Chronic kidney disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association between indoxyl concentration in heart failure patients with chronic kidney disease and the incidence of cardiovascular events
Basic objectives2
Others
Basic objectives -Others
Evaluation of pathophysiology of cardio-renal syndrome
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of all cause death, non fatal myocardial infarction, non fatal stroke, and hospitalization for heart failure during one-year follow up after acquisition of indoxyl sulfate concentration.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)history of hospitalization for heart failure
2)CKD stage 3B, 4, and 5
3)age >=20 and <85
4)patient who gave a written informed consent after sufficient explanation
Key exclusion criteria
1)history of hospitalization within 30 days
2)patient taking spherical carbonaceous adsorbent
3)patient on hemodialysis
4)patient with Nephrotic Syndrome
5)patient wiht polysistic kidney
6)patient who took any unaprooved medicine wihtin 180 days
7)patient wiht prognosis less than 12 months
8)woman who is pregnant
9)patient who is unsuitable for this study by the investigator
Target sample size
312
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hiroshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medcine
Zip code
7008558
Address
2-5-1 Shikata-Cho, Kikta-Ku, Okayama
TEL
086-235-7351
itomd@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Miyoshi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Cardiovascular Medcine
Zip code
7008558
Address
2-5-1 Shikata-Cho, Kikta-Ku, Okayama
TEL
086-235-7351
Homepage URL
miyoshit@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
KUREHA CORPORATION
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
The ethical committee of Okayama University
Address
2-5-1 Shikata-Cho, Kikta-Ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.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 | 03 | Month | 01 | 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
| 2018 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Indoxyl sulfate will be measured in a core laboratory. Then, the association between its concentration and cardiovascular events will be analysed.
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040837
| 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 |
