UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014374 |
|---|---|
| Receipt number | R000016730 |
| Scientific Title | Evaluation of vascular calcification in CKD patients |
| Date of disclosure of the study information | 2016/06/23 |
| Last modified on | 2014/06/25 15:39:36 |
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Basic information
Public title
Evaluation of vascular calcification in CKD patients
Acronym
Evaluation of vascular calcification in CKD patients
Scientific Title
Evaluation of vascular calcification in CKD patients
Scientific Title:Acronym
Evaluation of vascular calcification in CKD patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate vascular calcificationin CKD patients
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Mortality
Key secondary outcomes
1 ESRD(initiation of renal replacement therapy)
2 Total cardiovascular event
3 Serum creatinine doubling
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD G3-5(eGFR60ml/min/1.73m3 and fewer)
Key exclusion criteria
1 Inablity or un willingness to provide written informed concent
2 Patients who was initiated renal replacement therapy within a half year
3 Active infectious disease
4 Cancer
5 Inablity or un willingness to comply with the requirements of the protocol by investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keitaro Sato |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
Address
1-19-3 Hon-chyou Toda city, Saitam
TEL
048-442-1111
ksato@kc.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Harada, Keitaro Sato |
Organization
Toda Central General Hospital
Division name
Department of Nephrology
Zip code
Address
1-19-3 Hon-chyou Toda city, Saitam
TEL
048-442-1111
Homepage URL
ksato@kc.twmu.ac.jp
Sponsor or person
Institute
Toda Central General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective study to evaluate that the vascular calcification and renal prognosis for two-year observation. Moreover we will analyze which urine and serum markers would influence the renal prognosis.
Management information
Registered date
| 2014 | Year | 06 | Month | 25 | Day |
Last modified on
| 2014 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016730
