UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007096 |
|---|---|
| Receipt number | R000008349 |
| Scientific Title | A multicenter study of prognosis after the initiation of dialysis in patients with chronic kidney disease |
| Date of disclosure of the study information | 2012/01/18 |
| Last modified on | 2016/07/18 10:21:40 |
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Basic information
Public title
A multicenter study of prognosis after the initiation of dialysis in patients with chronic kidney disease
Acronym
Aichi cohort study of prognosis in patients newly initiated into dialysis (AICOPP)
Scientific Title
A multicenter study of prognosis after the initiation of dialysis in patients with chronic kidney disease
Scientific Title:Acronym
Aichi cohort study of prognosis in patients newly initiated into dialysis (AICOPP)
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of AICOPP is to clarify a relationship between pre-dialysis management and prognosis after the initiation of dialysis in patients with chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
All-cause mortality after initiation of dialysis
Key secondary outcomes
1) Cardiovascular events (admission due to heart failure, acute coronary syndrome, PCI, CABG, admission due to peripheral artery disease)
2) Admission due to infection
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
All patients in chronic kidney disease:
1) aged 20 years and over,
2) newly initiated into dialysis
Key exclusion criteria
All patients:
1) acute kidney injury,
2) death before discharge from hospital
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Inaguma Daijo |
Organization
Nagoya Daini Red Cross Hospital
Division name
Kidney Disease Center
Zip code
Address
Myoken-cho 2-9, Showa-ku, Nagoya, Japan
TEL
052-832-1121
inaguma@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inaguma Daijo |
Organization
Nagoya Daini Red Cross Hospital
Division name
Kidney Disease Center
Zip code
Address
Myoken-cho 2-9, Showa-ku, Nagoya, Japan
TEL
052-832-1121
Homepage URL
inaguma@nagoya2.jrc.or.jp
Sponsor or person
Institute
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Jinzou Zaidan
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
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 | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2012 | Year | 01 | Month | 18 | Day |
Last modified on
| 2016 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008349
