UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028289 |
|---|---|
| Receipt number | R000032298 |
| Scientific Title | Diverse in PTH values measured by CLIA and ECLIA methods: the influence on managing indicators of CKD patients |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2017/07/19 09:11:22 |
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Basic information
Public title
Diverse in PTH values measured by CLIA and ECLIA methods: the influence on managing indicators of CKD patients
Acronym
PTH measuring methods and management of CKD
Scientific Title
Diverse in PTH values measured by CLIA and ECLIA methods: the influence on managing indicators of CKD patients
Scientific Title:Acronym
PTH measuring methods and management of CKD
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To offer a basic data to convert values of intact PTH between CLIA method and ECLIA method, correlation of values indicated by both methods are examined with serum of CKD patients.
Basic objectives2
Others
Basic objectives -Others
To consider the relationship between values of intact PTH measured by CLIA method and managing indicators of CKD patients, evaluate biochemical and bone metabolism markers.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
An correlation between values of intact PTH measured by ECLIA and CLIA methods, and a basic data to convert them each other
Key secondary outcomes
An estimation of effective managing indicator of CKD in cases of using CLIA method for measuring intact PTH
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
CKD patients at dialysis and predialysis stages
Key exclusion criteria
patients whose agreements had not been obtained
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Tokai University Hachioji Hospital
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
1838 Ishikawacho Hachioji Tokyo 192-0032
TEL
042-639-1111
kakuta@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi Kakuta |
Organization
Tokai University Hachioji Hospital
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
Address
1838 Ishikawacho Hachioji Tokyo 192-0032
TEL
042-639-1111
Homepage URL
kakuta@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Tokai 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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東海大学付属八王子病院（東京都）、北八王子クリニック（東京都）、小平北口クリニック（東京都）、本厚木メディカルクリニック（神奈川県）、望星平塚クリニック（神奈川県）、湘南星和クリニック（神奈川）、東大和南街クリニック（神奈川県）、京王八王子山川クリニック（東京都）、八王子東町クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Correlation between values of intact PTH indicated by ECILA and CILA methods was detected from data of about 300 patients. (2017 July).
Management information
Registered date
| 2017 | Year | 07 | Month | 19 | Day |
Last modified on
| 2017 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032298
