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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035850
Receipt No. 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 2019/08/13

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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
Email 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
Email miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 19 Day
Date of IRB
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
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040837

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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