UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060009 |
|---|---|
| Receipt number | R000068634 |
| Scientific Title | Anticoagulation therapy for dialysis patients |
| Date of disclosure of the study information | 2025/12/08 |
| Last modified on | 2025/12/08 11:17:12 |
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Basic information
Public title
Anticoagulation therapy for dialysis patients
Acronym
Anticoagulation therapy for dialysis patients
Scientific Title
Anticoagulation therapy for dialysis patients
Scientific Title:Acronym
Anticoagulation therapy for dialysis patients
Region
| Japan |
Condition
Condition
dialysis patients
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of anticoagulation therapy for maintenance dialysis patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
all cause death
cardiovascular death
death from ischemic heart disease
death from hemorrhage
hemorrhagic cardiovascular death
Key secondary outcomes
cerebral infarction
ishcemic heart disease
heart failure
peripheral artery disease
vascular access failure
systemic thrombosis
cerebral hemorrhage
gasterointestinal hemorrhage
severe systemic hemorrhage
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
maintenance dialysis patients affiliated with the institutions participating Hyogo association of dialysis physicians
Key exclusion criteria
patients refusing to participate this study
patients with insufficient data
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Kono |
Organization
Kobe university graduate school of medicine
Division name
Division of Nephrology
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe city, Hyogo Pref
TEL
078-382-6500
kkono@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Kono |
Organization
Kobe university graduate school of medicine
Division name
Division of Nephrology
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe city, Hyogo Pref
TEL
078-382-6500
Homepage URL
kkono@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Nephrology, Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese association of dialysis physicians
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical and translational research center, Kobe university hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe city, Hyogo Pref
Tel
078-382-6669
ctrcedu-seminar@med.kobe-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
| 2025 | Year | 12 | Month | 08 | 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
3813
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068634
