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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name