UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033029 |
|---|---|
| Receipt number | R000037654 |
| Scientific Title | Clinical utility of urinary gravity / osmolality ratio as an alternate of selectivity index in CKD with proteinuria |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2022/06/20 14:39:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical utility of urinary gravity / osmolality ratio as an alternate of selectivity index in CKD with proteinuria
Acronym
Urinary gravity/osmolality ration in CKD patients
Scientific Title
Clinical utility of urinary gravity / osmolality ratio as an alternate of selectivity index in CKD with proteinuria
Scientific Title:Acronym
Urinary gravity/osmolality ration in CKD patients
Region
| Japan |
Condition
Condition
chronic kidney disease (CKD) with proteinuria
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical significance of urinary gravity/osmolality ratio as an alternate of selectivity index in differential diagnosis of CKD with proteinuria
Basic objectives2
Others
Basic objectives -Others
To evaluate clinical significance of urinary gravity/osmolality ratio as a prognostic marker of CKD with proteinuria
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity, specificity, and ROC curve of urinary gravity/osmolality ratio in comparison with selectivity index of urinary protein
Key secondary outcomes
trajectory patterns of urinary gravity/osmolality ratio in clinical course of CKD with proteinuria, especially nephrotic syndrome
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
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CKD patients with proteinuria
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
271-0068
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81-297-74-5551
yoshimaeda43@toride-medical.or.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
271-0068JA
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81-297-74-5551
Homepage URL
yoshimaeda43@toride-medical.or.jp
Sponsor or person
Institute
Nephrology division, JA Toride Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nephrology division, JA Toride Medical Center
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
JA Toride Medical Center
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
Tel
81297745551
jimujityo@toride-medical.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
JAとりで総合医療センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
http://www.toride-medical.or.jp/
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
| Delay expected |
Results Delay Reason
Incompleted final analysis
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
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
The concise protocol is opened in the HomePage of JA Toride Medical Center
Management information
Registered date
| 2018 | Year | 06 | Month | 17 | Day |
Last modified on
| 2022 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037654
