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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007524
Receipt No. 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

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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
Email

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
Email ana65641@nifty.com

Sponsor
Institute Department of Integrated Therapy for Chronic Kidney Disease, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008886

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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