UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014778 |
|---|---|
| Receipt number | 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 14:25:41 |
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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
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
ty812@kanamecho-hp.jp
Sponsor or person
Institute
Kanamecho Hospital
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017166
| 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 |
