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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015154
Receipt No. R000017606
Scientific Title The effect of soluble inhibitors of Wnt signaling on mineral and bone metabolism in patinets undergoing peritoneal dialysis
Date of disclosure of the study information 2014/09/15
Last modified on 2015/03/26

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Basic information
Public title The effect of soluble inhibitors of Wnt signaling on mineral and bone metabolism in patinets undergoing peritoneal dialysis
Acronym soluble inhibitors of Wnt signaling in PD patients
Scientific Title The effect of soluble inhibitors of Wnt signaling on mineral and bone metabolism in patinets undergoing peritoneal dialysis
Scientific Title:Acronym soluble inhibitors of Wnt signaling in PD patients
Region
Japan

Condition
Condition Endstage Kidney Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of soluble inhibitors of Wnt signaling in patients undergoing peritoneal dialysis
Basic objectives2 Others
Basic objectives -Others To determine the association between serum levels of sclerostin and Dkk-1 and serum biochemical parameters and bone metabolic markers
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Serum levels of sclerostin and Dkk-1
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who received peritoneal dialysis therapy during January 2010 and May 2014 at Kyushu University Hospital, and gave written-informed consent.
Key exclusion criteria Patients who did not give written informed consent
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Yamada
Organization Kyushu University Hospital
Division name Kidney Care Unit
Zip code
Address Maidashi3-1-1, Hiashi-Ku, Fukuoka
TEL 092-642-5843
Email ana65641@nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Yamada
Organization Kyushu University Hospital
Division name Kidney Care Unit
Zip code
Address Maidashi3-1-1, Higashiku, Fukuoka
TEL 092-642-5843
Homepage URL
Email ana65641@nifty.com

Sponsor
Institute Department of Kidney Care Unit, Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
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 YES
Study ID_1 No 24-56
Org. issuing International ID_1 Kyushu University Hospital Center for Clinical and Translational Research
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 09 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Both sclerostin and Dkk-1 were excreted into urine and peritoneal dialysate. Multivariable analyses showed that serum sclerostin was significantly associated with age, sex, renal Kt/V, and serum PTH level and serum Dkk-1 was significantly associated with platelet count and serum FGF23 level.
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
2014 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 15 Day
Last follow-up date
2015 Year 01 Month 31 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 01 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information Both sclerostin and Dkk-1 were excreted into urine and peritoneal dialysate. Multivariable analyses showed that serum sclerostin was significantly associated with age, sex, renal Kt/V, and serum PTH level and serum Dkk-1 was significantly associated with platelet count and serum FGF23 level.

Management information
Registered date
2014 Year 09 Month 14 Day
Last modified on
2015 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017606

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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