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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014778
Receipt No. R000017166
Scientific Title Prevalence of chronic kidney diseases in patients with chronic obstructive pulmonary disease: assessment based on glomerular filtration rate estimated from creatinine and cystatin C
Date of disclosure of the study information 2014/08/10
Last modified on 2014/08/06

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Basic information
Public title Prevalence of chronic kidney diseases in patients with chronic obstructive pulmonary disease:
assessment based on glomerular filtration rate estimated from creatinine and cystatin C
Acronym Prevalence of CKD in COPD patients
Scientific Title Prevalence of chronic kidney diseases in patients with chronic obstructive pulmonary disease:
assessment based on glomerular filtration rate estimated from creatinine and cystatin C
Scientific Title:Acronym Prevalence of CKD in COPD patients
Region
Japan

Condition
Condition COPD,CKD
Classification by specialty
Medicine in general Pneumology Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to investigate the prevalence of CKD in COPD patients using estimated glomerular filtration rate (eGFR) based on creatinine (Cr) and cystatin C (Cys).
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the prevalence of CKD
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria stable COPD outpatients and outpatients who visited our hospital during the same period, are aged 60 or more, and did not have a history of COPD or kidney disease
Key exclusion criteria The patient that an agreement is not provided
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takayuki Yoshizawa
Organization Kanamecho Hospital
Division name Department of Internal Medicine
Zip code
Address 1-11-13 Kanamecho, Toshima-ku, Tokyo, Japan
TEL 03-3957-3181
Email ty812@kanamecho-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Yoshizawa
Organization Kanamecho Hospital
Division name Department of Internal Medicine
Zip code
Address 1-11-13 Kanamecho, Toshima-ku, Tokyo, Japan
TEL 03-3957-3181
Homepage URL
Email ty812@kanamecho-hp.jp

Sponsor
Institute Kanamecho Hospital
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 10 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
CKD is a comorbidity that occurs frequently in COPD patients, and we believe that renal function in COPD patients should preferably be evaluated based not only on Cr but also in combination with Cys. 

The congress of the japan society for respiratory care and rehabilitation (November, 2012)
The congress of the japanease respiratory society (April, 2013)
The congress of the japanease society of internal medicine (April, 2013)
The congress of the japan physicians association (October, 2013)
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
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The Cys level was significantly higher and eGFRCys was significantly lower in the COPD group . While the prevalence of CKD evaluated based on eGFRCr was 31% in the COPD group and 8% in the non-COPD group , the evaluated prevalence based on eGFRCys was 53% in the COPD group and 15% in the non-COPD group , demonstrating an even higher prevalence.

Management information
Registered date
2014 Year 08 Month 06 Day
Last modified on
2014 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017166

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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