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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020925
Receipt No. 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

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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
Email 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
Email 8211sy01@hosp.go.jp

Sponsor
Institute NHO Kumamoto Saishunsou National Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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