UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013307 |
|---|---|
| Receipt number | R000015522 |
| Scientific Title | Association between selum Klotho, sleep-disordered breathing and long term prognosis in heamodialysis patients |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2016/03/02 05:14:49 |
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Basic information
Public title
Association between selum Klotho, sleep-disordered breathing and long term prognosis in heamodialysis patients
Acronym
Serum Klotho and sleep-disordered breathing in dialysis
Scientific Title
Association between selum Klotho, sleep-disordered breathing and long term prognosis in heamodialysis patients
Scientific Title:Acronym
Serum Klotho and sleep-disordered breathing in dialysis
Region
| Japan |
Condition
Condition
end stage renal disease
Classification by specialty
| Cardiology | Pneumology | Nephrology |
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship among serum Klotho, sleep-disordered breathing and long-term prognosis in dialysis patients
Basic objectives2
Others
Basic objectives -Others
Evaluation of prognostic factors
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
mortality
Key secondary outcomes
cardiovascular event
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Mmaintainance hemodialysis patients in Japanese Red-cross Koga Hospital
Key exclusion criteria
malignat disease
acute pulmonary disease
patients without acceptance
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Masuda |
Organization
Jichi Medical University
Division name
Division of Neprhology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7346
takam@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Masuda |
Organization
Jichi Medical University
Division name
Division of Nephrology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL
0285-58-7346
Homepage URL
takam@jichi.ac.jp
Sponsor or person
Institute
Division of Nephrology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Dialysis Outcome Research Group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Red Cross Koga Hospital
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
古河赤十字病院(茨城県)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.hindawi.com/journals/ije/2015/406269/abs/
Number of participants that the trial has enrolled
Results
We prospectively followed a cohort of 63 patients with a mean duration of chronic hemodialysis of years for a median of 65 months. Serum soluble Klotho was detectable in all patients (median 371 pg/mL, interquartile range 309 to 449). Patients with serum soluble Klotho levels below the lower quartile (<309 pg/mL) had significantly higher cardiovascular and all-cause mortality rates. Furthermore, the higher all-cause mortality persisted even after adjustment for confounders (hazard ratio 4.14, confidence interval 1.29-13.48). We conclude that there may be a threshold for the serum soluble Klotho level associated with a higher risk of mortality.
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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | 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
Using blood sample, serum Klotho level will be measured. We observe long term prognosis between low and high serum Klotho. We also test sleep apnea at the same time of blood collection.
Management information
Registered date
| 2014 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015522
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
