UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007988 |
|---|---|
| Receipt number | R000009402 |
| Scientific Title | Multicenter database study of chronic kidney disease: the Fukuoka Kidney Registry |
| Date of disclosure of the study information | 2012/05/19 |
| Last modified on | 2022/11/26 11:09:27 |
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Basic information
Public title
Multicenter database study of chronic kidney disease: the Fukuoka Kidney Registry
Acronym
The Fukuoka Kidney Registry (FKR)
Scientific Title
Multicenter database study of chronic kidney disease: the Fukuoka Kidney Registry
Scientific Title:Acronym
The Fukuoka Kidney Registry (FKR)
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Classification by specialty
| Cardiology | Nephrology | Geriatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the factors involved in the development and progression of chronic kidney disease, including the analysis of genetic and environmental factors
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
End-stage renal disease
Key secondary outcomes
Total mortality
Cardiovascular disease
Pathophysiology
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients
Key exclusion criteria
None
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Kitazono |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5256
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Nakano |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Medicine and Clinical Science
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5843
Homepage URL
toshink@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
None.
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
Human genome / genetic analysis research ethics review committee
Address
812-8582, Maidashi 3-1-1, Higashi-ku, Fukuoka
Tel
092-642-6772
ijkseimei@jimu.kyushu-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
| 2012 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10157-016-1294-4
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10157-016-1294-4
Number of participants that the trial has enrolled
4476
Results
The odds ratios (ORs) for reduced kidney function increased linearly as the number of major comorbid conditions increased (OR for 1-2 conditions: 2.22, 95% confidence interval [CI]: 1.65-2.97; OR for 3-4 conditions: 3.04, 95% CI: 2.12-4.37; OR for >/= 5 conditions: 4.37, 95% CI: 1.75-10.9).
Results date posted
| 2022 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The mean age of patients was 67 years (male, 56.0%). The prevalence of hypertension, diabetes mellitus, dyslipidemia, prior CVD, cancer, and bone fracture, which are the major comorbidities, was 83.3%, 28.7%, 45.9%, 23.3%, 12.7%, and 6.3%, respectively.
Participant flow
We performed a cross-sectional analysis of the association between 23 comorbid conditions and reduced kidney function in 4,476 patients with non-dialysis-dependent CKD enrolled in a multicenter cohort in Japan. Reduced kidney function was defined as an estimated glomerular filtration rate of </= 60 mL/min/1.73 m(2).
Adverse events
none
Outcome measures
Impaired renal function (defined as estimated glomerular filtration rate [eGFR] <60 mL/min/1.73m2) defined as <60 mL/min/1.73 m2)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will register chronic kidney disease patients attending kidney care facilities in northern Kyushu and conduct a prospective follow-up. We will investigate the pathophysiology and treatment and perform genetic analysis.
Management information
Registered date
| 2012 | Year | 05 | Month | 19 | Day |
Last modified on
| 2022 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009402
