UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041335 |
|---|---|
| Receipt number | R000047200 |
| Scientific Title | The association of salivary Proline Rich Proteins(PRPs) with cardio-renal outcome and vascular calcification: a prospective cohort study |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2024/02/08 10:27:13 |
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Basic information
Public title
The association of salivary Proline Rich Proteins(PRPs) with cardio-renal outcome and vascular calcification: a prospective cohort study
Acronym
PRPs study
Scientific Title
The association of salivary Proline Rich Proteins(PRPs) with cardio-renal outcome and vascular calcification: a prospective cohort study
Scientific Title:Acronym
PRPs study
Region
| Japan |
Condition
Condition
heart disease and kidney disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the association of salivary PRPs with heart disease, kidney disease and vascular calcification.
Basic objectives2
Others
Basic objectives -Others
Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in eGFR, onset of CKD, >30% reduction in eGFR from baseline, coronary artery calcification score, aortic valve calcification score and mitral valve calcification score.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients or hospitalized patients who are diagnosed with heart disease, kidney disease, diabetes or hypertension.
Key exclusion criteria
Patients judged by the investigator to be unsuitable as subjects.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Tsuruya |
Organization
Nara medical university hospital
Division name
Department of nephrology
Zip code
634-8522
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
tsuruya@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Tsuruya |
Organization
Nara medical university hospital
Division name
Department of nephrology
Zip code
634-8522
Address
840 Shijocho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
tsuruya@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Nara medical 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
Institute of Clinical and Translational Science, Nara Medical University
Address
840 Shijocho, Kashihara, Nara, Japan
Tel
0744-22-3051
ethics_nara@naramed-u.ac.jp
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
| 2020 | Year | 09 | 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
1072
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective cohort study
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047200
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