UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007524 |
|---|---|
| Receipt number | R000008886 |
| Scientific Title | Clinical usefulness of measuring tartrate-resistant acid phosphatase 5b in predicting bone turnover in peritoneal dialysis patients |
| Date of disclosure of the study information | 2012/03/19 |
| Last modified on | 2012/11/12 15:01:26 |
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Basic information
Public title
Clinical usefulness of measuring tartrate-resistant acid phosphatase 5b in predicting bone turnover in peritoneal dialysis patients
Acronym
Clinical Usefulness of measurement of TRACP5b in PD patients
Scientific Title
Clinical usefulness of measuring tartrate-resistant acid phosphatase 5b in predicting bone turnover in peritoneal dialysis patients
Scientific Title:Acronym
Clinical Usefulness of measurement of TRACP5b in PD patients
Region
| Japan |
Condition
Condition
Endstage renal failure patients on peritoneal dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical usefulness of measuring serum TRACP5b in peritoneal dialysis patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the relationship between TRACP5b and other established bone turnover markers
Key secondary outcomes
To determine the effect of residual kidney function and peritoneal dialysis treatment of bone markers includin TRACP5b
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 receives peritoneal dialysis treatment at Kyushu University Hospital
Key exclusion criteria
Patients who did not give written informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Tsuruya |
Organization
Kyushu University
Division name
Department of Integrated Thearpy for Chronic Kidney Disease, Graduate School of Medical Sciences
Zip code
Address
3-1-1Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5843
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Yamada |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address
3-1-1Maidashi, Higashi-Ku, Fukuoka
TEL
092-642-5256
Homepage URL
http://www.c-shop.net/kyudai_kcu/index.html
ana65641@nifty.com
Sponsor or person
Institute
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 03 | Month | 19 | Day |
Related information
URL releasing protocol
http://www.c-shop.net/kyudai_kcu/index.html
Publication of results
Published
Result
URL related to results and publications
http://www.c-shop.net/kyudai_kcu/index.html
Number of participants that the trial has enrolled
Results
Serum Tartrate resistant acid phosphatase 5b shows linear relationship with other bone metabolic markers including NTX, PTH, and BAP. Serum TRACP5b was not influenced by residual renal function.
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
| 2012 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
Now under resitration
Management information
Registered date
| 2012 | Year | 03 | Month | 18 | Day |
Last modified on
| 2012 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008886
| 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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| Registered date | File name |
