UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020925 |
|---|---|
| Receipt number | R000019621 |
| Scientific Title | Prevalence of chronic renal disease (CKD) in patients with rheumatoid arthritis (RA), |
| Date of disclosure of the study information | 2016/02/08 |
| Last modified on | 2017/08/30 12:22:06 |
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Basic information
Public title
Prevalence of chronic renal disease (CKD) in patients with rheumatoid arthritis (RA),
Acronym
Prevalence of CKD in patients with RA,
Scientific Title
Prevalence of chronic renal disease (CKD) in patients with rheumatoid arthritis (RA),
Scientific Title:Acronym
Prevalence of CKD in patients with RA,
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence of CKD in rheumatoid arthritis patients and the risk factors of CKD development
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of CKD in RA patients
Risk factors associated with CKD development
Key secondary outcomes
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All outpatients who visited during 3 months.
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Mori |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Rheumatology
Zip code
Address
2659 Suya, Kohshi Japan
TEL
81-96-242-1000
moris@saisyunsou1.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kokubo Katsunori |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Secretariat
Zip code
Address
2659 Suya, Kohshi Japan
TEL
81-96-242-1000
Homepage URL
8211sy01@hosp.go.jp
Sponsor or person
Institute
NHO Kumamoto Saishunsou National Hospital
Institute
Department
Personal name
Funding Source
Organization
NHO Kumamoto Saishunsou National Hospital
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
熊本再春荘病院（熊本県）、佐世保中央病院（長崎県）、吉玉リウマチ科内科（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
A total of 1908 patients with RA were included in this study. The prevalence of renal dysfunction based on absolute eGFR and BSA-indexed eGFR was determined. Risk factors were analyzed in multivariate logistic regression analysis.
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
Main results already published
Date of protocol fixation
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Between October 2014 and May 2015, we consecutively recruited RA patients at outpatient clinics of community hospitals in Japan. Renal dysfunction was defined as an absolute estimated glomerular filtration rate (eGFR) < 60 ml/min or body surface area (BSA)-indexed eGFR < 60 ml/min/1.73 m2. Demographic and clinical characteristics were compared between patients with and without renal dysfunction. Associations between renal dysfunction and possible risk factors were examined by multivariate logistic regression analysis.
Management information
Registered date
| 2016 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019621
| 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 |
