UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015154 |
|---|---|
| Receipt number | 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 14:16:52 |
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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
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
ana65641@nifty.com
Sponsor or person
Institute
Department of Kidney Care Unit, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
