UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009529 |
|---|---|
| Receipt number | R000010880 |
| Scientific Title | Implication of clinical management in predialysis chronic renal failure and induction of hemodialysis, and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2020/06/23 16:16:16 |
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Basic information
Public title
Implication of clinical management in predialysis chronic renal failure and induction of hemodialysis, and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Acronym
Implication of predialysis management and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Scientific Title
Implication of clinical management in predialysis chronic renal failure and induction of hemodialysis, and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Scientific Title:Acronym
Implication of predialysis management and incidents of cardiovascular events and vascular access failure in maintenance hemodialysis
Region
| Japan |
Condition
Condition
Predialysis and hemodialysis chronic renal failure
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of clinical management in predialysis renal failure and induction of hemodialysis on incidents of cardiovascular events and vascular access failure in early maintenance hemodialysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Cardiovascular events and death
Cardiovascular events: Myocardial infarction, stroke, revascularization of coronary artery (PCI/CABG), admission for heart failure and revascularization for arteriosclerotic obliterans
2) Vascular access failure
Vascular access failure: occlusion of vascular access or intervention for the failure (Operation/PTA)
Key secondary outcomes
1) All-caused death
2) All-caused admission
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with chronic renal failure expected to initiate maintenance hemodialysis in clinical institutions which have accepted to participate in this study
2) Patients with the informed consent to this study by themselves or the relatives
Key exclusion criteria
1) Patients receiving dialysis for acute kidney injury
2) Patients with any events defined as the primary outcome in this study during the hospitalization for induction of maintenance hemodialysis
3) Patients with peritoneal dialysis
4) Patients with the past history of kidney transplantation
5) Patients receiving treatment for advanced cancer with unfavorable prognosis
6) Patients receiving treatment for severe infection with unfavorable prognosis
7) Patients with heart failure who feel the rest symptom (NYHA classification IV)
8) Patients who are unable to receive the outpatient hemodialysis by their walk after the induction
9) Patients judged as unsuitable for participating in this study by the attending physician
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamaki Sasaki |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
tsasaki@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshisuke Haruna |
Organization
Kawasaki Medical School
Division name
Department of Nephrology and Hypertension
Zip code
Address
577 Matsushima, Kurashiki, Okayama 701-0192
TEL
086-462-1111
Homepage URL
hrn444k@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Nephrology and Hypertension, Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 01 | 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
This research was canceled.
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 | 12 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the effects of clinical factors in predialysis chronic renal failure and induction of hemodialysis on incidents of cardiovascular events and vascular access failure in maintenance hemodialysis.
Management information
Registered date
| 2012 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010880
| 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 |
