UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040848 |
|---|---|
| Receipt number | R000046640 |
| Scientific Title | Study on construction of comprehensive database for patients with chronic kidney disease in Fukushima Prefecture |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2023/12/25 09:19:22 |
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Basic information
Public title
Study on construction of comprehensive database for patients with chronic kidney disease in Fukushima Prefecture
Acronym
Fukushima CKD Cohort study
Scientific Title
Study on construction of comprehensive database for patients with chronic kidney disease in Fukushima Prefecture
Scientific Title:Acronym
Fukushima CKD Cohort study
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the characteristics and outcomes, such as cardiovascular events, ESRD, and death of pre-dialysis patients with CKD.
Basic objectives2
Others
Basic objectives -Others
Observational survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular events, ESRD, and death
Key secondary outcomes
Doubling of serum creatinine, eGFR decline.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 years or over
2) CKD according to the definition of an estimated
GFR, <60 mL/min/1.73 m2 or positive dipstick results for
proteinuria
Key exclusion criteria
1) receiving dialysis treatment in the last three months
2) Active malignancy
3) Infectious disease
4) Pregnancy
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Junichiro |
| Middle name | James |
| Last name | Kazama |
Organization
Fukushima Medical University
Division name
Department of Nephrology and Hypertension
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima
TEL
024-547-1111
jinnai@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanaka |
Organization
Fukushima Medical University
Division name
Department of Nephrology and Hypertension
Zip code
960-1295
Address
1, Hikarigaoka, Fukushima
TEL
024-547-1111
Homepage URL
kennichi@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Medical Research Promotion, Fukushima Medical University
Address
1, Hikarigaoka, Fukushima
Tel
024-547-1825
rs@fmu.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
| 2020 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/31875937/
Publication of results
Partially published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/33411113/
Number of participants that the trial has enrolled
2724
Results
Serum potassium levels, phosphorus levels, hematological parameters of anemia, and polypharmacy were associated with poor prognosis of CKD patients.
Results date posted
| 2023 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See below for detail
https://pubmed.ncbi.nlm.nih.gov/31875937/
Participant flow
See below for detail
https://pubmed.ncbi.nlm.nih.gov/33411113/
Adverse events
NA (observational study)
Outcome measures
See below for detail
https://pubmed.ncbi.nlm.nih.gov/33411113/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2020 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046640
| 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 |
