UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032150 |
|---|---|
| Receipt number | 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 | 2023/08/06 13:02:49 |
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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
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
ogi@yuurinkouseikai.or.jp
Sponsor or person
Institute
Yuurinkouseikai Fuji Hospital
Institute
Department
Personal name
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
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
DOI:1007/s10157-021-02027-6 DOI:10.1186/s12882-022-02974-6
Publication of results
Published
Result
URL related to results and publications
DOI:1007/s10157-021-02027-6 DOI:10.1186/s12882-022-02974-6
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
Non-diabetes mellitus
n=197
Age(mean) 68.9 years
Sex male:female 124:73
Diabetes mellitus
n=106
Age(mean) 67.1 years
Sex male:female 70:36
Participant flow
The subjects included Japanese patients with lifestyle-related diseases of 18 years or older of age, with an eGFR of 15 ml/min/1.73m2 or more and a urinary protein-to-creatinine ratio (uPCR) of <0.5g/gCr at initiation. Patients with urinary tract infection, nephritis, hereditary renal disease, paraproteinemia, or cancer were excluded.
Microalbuminuria was defined as a urinary albumin-to-creatinine ratio (uACR) of 30-299 mg/gCr on at least two of three measurements.
The receicer operating characteristic (ROC) curve was used to obtain the cut-off value with the largest (Sensitivity + Specificiy-1).
Adverse events
None
Outcome measures
A single uPCR was useful for differentiating normoalbuminuria and micro- and macroalbuminuria in both nondiabetics and diabetics.
The cut-off value of the second uPCR measurements in nondiabetics was 0.09g/gCr (AUC0.89, Sensitivity 0.76, Specificity 0.89) in G1-4 (n=197) and 0.07 g/gCr (AUC 0.92, Sensitivity 0.85, Specificity 0.88) in G1-3a (n=125).
The cut-off value of the second uPCR measurements in diabetics was 0.06 g/gCr (AUC 0.83, Sensitivity 0.86, Specificity 0.69) in G1-4 (n=106).
Using the sum of three uPCR measurements was more useful than a single uPCR for differentiating microalbuminuria in non-diabetic lifestyle disease [cut-off value 0.23g/gCr (AUC 0.92, sensitivity 0.88, specificity 0.84) ].
When examining the correlation of changes in the uACR and uPCR, after dividing the first uPCR in non-diabetics and diabetics into greater than and less than 0.15 g/gCr, a posirive correlation was confirmed with respect to the change of 2 - 1 times and 3 - 2 times when the first uPCR was less than and greater than 0.15 g/gCr.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036676
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