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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032150
Receipt No. R000036676
Scientific Title Association between albuminuria and proteinuria in patients with lifestyle disease and chronic kidney disease
Date of disclosure of the study information 2018/04/15
Last modified on 2019/07/21

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Basic information
Public title Association between albuminuria and proteinuria in patients with lifestyle disease and chronic kidney disease
Acronym Association between albuminuria and proteinuria
Scientific Title Association between albuminuria and proteinuria in patients with lifestyle disease and chronic kidney disease
Scientific Title:Acronym Association between albuminuria and proteinuria
Region
Japan

Condition
Condition lifestyle disease
chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to clarify whether proteinuria distinguishes microalbuminuria from normoalbuminuria in patients with lifestyle disease and chronic kidney disease.
Basic objectives2 Others
Basic objectives -Others The second objective is to clarify whether change of proteinuria predicts chnage of microalbuminuria.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cut off value of proteinuria which distinguishes microalbuminuria from normoalbuminuria
Key secondary outcomes Association between change of microalbuminuria and proteinuria

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with lifestyle disease and chronic kidney disease
Key exclusion criteria Patients with proteinuria2(+) or more
Patients with urinary protein0.50g/gCr or more
Patients with urinary tract infection
Patients with CKD stage 5
The patient that written consent is not obtained
Target sample size 250

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Ogi
Organization Yuurinkouseikai Fuji Hospital
Division name Department of Internal Medicine
Zip code 412-0043
Address 1784 Niihashi Gotemba Shizuoka
TEL 0550-83-3333
Email ogi@yuurinkouseikai.or.jp

Public contact
Name of contact person
1st name Makoto
Middle name
Last name Ogi
Organization Yuurinkouseikai Fuji Hospital
Division name Department of Internal Medicine
Zip code 412-0043
Address 1784 Niihashi Gotemba Shizuoka
TEL 0550-83-3333
Homepage URL
Email ogi@yuurinkouseikai.or.jp

Sponsor
Institute Yuurinkouseikai Fuji Hospital
Institute
Department

Funding Source
Organization Yuurinkouseikai Fuji Hospital
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 Yuurinkouseikai Fuji Hospital
Address 1784 Niihashi Gotemba Shizuoka
Tel 0550-83-3333
Email hospital@yuurinkouseikai.or.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
2018 Year 04 Month 15 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 275
Results
UP and UAlb indicated a positive correlation after 808 measurements, and the UP corresponding to UAlb 30 mg/g Cr was 0.054g/gCr. 
UP was used to determine those with UAlb of less than or greater than 30mg/gCr by the ROC curve, indicating CO 0.09g/g Cr, AUC 0.886, p<0.0001. 
A single UP and the sum of three UPs were useful for respectively predicting microalbuminuria (UAlb 30 to 299 mg/g Cr at least twice for 3 UAlbs) in 275 cases .
The difference between UP and UAlb showed a positive correlation.
Results date posted
2019 Year 07 Month 21 Day
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
2017 Year 09 Month 07 Day
Date of IRB
2017 Year 09 Month 07 Day
Anticipated trial start date
2018 Year 04 Month 09 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In patients with lifestyle disease and chronic kidney other than diabetes mellitus, it is not allowed to mesure albuminuria using insurance in Japan. The method for predicting microalbuiminuria is needed. If microalbuminuria can be predicted from proteinuria, it is clinically useful.

Management information
Registered date
2018 Year 04 Month 08 Day
Last modified on
2019 Year 07 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036676

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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