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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041335
Receipt No. 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 2020/08/06

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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 Yoshihiko
Middle name
Last name Saito
Organization Nara medical university hospital
Division name Department of cardiovascular medicine
Zip code 634-8522
Address 840 Shijocho, Kashihara, Nara, Japan
TEL 0744-22-3051
Email yssaito@naramed-u.ac.jp

Public contact
Name of contact person
1st name Yoshihiko
Middle name
Last name Saito
Organization Nara medical university hospital
Division name Department of cardiovascular medicine
Zip code 634-8522
Address 840 Shijocho, Kashihara, Nara, Japan
TEL 0744-22-3051
Homepage URL
Email yssaito@naramed-u.ac.jp

Sponsor
Institute Nara medical university hospital
Institute
Department

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
Email 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
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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 06 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 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
2020 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047200

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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