UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002904 |
|---|---|
| Receipt number | R000003540 |
| Scientific Title | The antiproteinuric effect of CPAP in chronic kidney disease patients complicated with obstructive sleep apnea |
| Date of disclosure of the study information | 2009/12/18 |
| Last modified on | 2015/06/25 19:48:57 |
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Basic information
Public title
The antiproteinuric effect of CPAP in chronic kidney disease patients complicated with obstructive sleep apnea
Acronym
Effect of CPAP in chronic kidney disease complicated with obstructive sleep apnea
Scientific Title
The antiproteinuric effect of CPAP in chronic kidney disease patients complicated with obstructive sleep apnea
Scientific Title:Acronym
Effect of CPAP in chronic kidney disease complicated with obstructive sleep apnea
Region
| Japan |
Condition
Condition
non-dialysis chronic kidney disease
obstructive sleep apnea
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the proteinuria reduction effect of CPAP in non-dialysis chronic kidney disease patients with obstructive sleep apnea
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison with urinary protein before and after 8-week therapy with CPAP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CPAP group:
eight-week treatment of continuous positive airway pressure (CPAP)
Interventions/Control_2
Control group:
Patients who reject continuous positive airway pressure (CPAP) treatment.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-dialysis chronic kidney disease patients who are diagnosed with obstructive sleep apnea by polysomnography. Apnea-hypopnea index is 20 or more.
Key exclusion criteria
1)Patients with proteinuria less than 0.5g/day
2)Patients with severe complications or active infection
3)Patients with rapidly deteriorated renal function
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Sakaguchi |
Organization
Osaka general medical cneter
Division name
Nephrology and Hypertension
Zip code
Address
3-1-56 Manndaihigashi, sumiyoshi-ku, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka general medical center
Division name
Nephrology and Hypertension
Zip code
Address
TEL
Homepage URL
yusuke7771@excite.co.jp
Sponsor or person
Institute
Osaka general medical center
Nephrology and Hypertension
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharmaceuticals
Organization
Division
Category of Funding Organization
Profit organization
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
| 2009 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 15 | Day |
Last modified on
| 2015 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003540
| 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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