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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013307
Receipt No. 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

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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
Email 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
Email takam@jichi.ac.jp

Sponsor
Institute Division of Nephrology, Jichi Medical University
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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