UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005474
Receipt number R000006485
Scientific Title The study of novel kidney proteins in normal and renal diseases
Date of disclosure of the study information 2011/04/20
Last modified on 2017/04/24 11:20:28

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Basic information

Public title

The study of novel kidney proteins in normal and renal diseases

Acronym

The study of novel kidney proteins in normal and renal diseases

Scientific Title

The study of novel kidney proteins in normal and renal diseases

Scientific Title:Acronym

The study of novel kidney proteins in normal and renal diseases

Region

Japan


Condition

Condition

renal diseases

Classification by specialty

Nephrology Pediatrics Adult
Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate novel kidney proteins in normal and renal diseases.

Basic objectives2

Others

Basic objectives -Others

pathophysiology

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation of novel kidney proteins in normal and renal diseases

Key secondary outcomes

Differential diagnosis of renal diseases by evaluation of novel kidney proteins


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Evaluation of novel kidney proteins in normal and renal diseases.

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

1 years-old <=

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

normal: 1)the patient who undergo an operation for kidney 2)the patient who consent 3)10 cases renal diseases: 1)the patient who undergo a renal biopsy 2)the patient who consent 3)50 cases nephrotic syndrome IgA nephropathy Henoch-Schonlein purpura nephritis other glomerular diseases

Key exclusion criteria

1)positive for HBV, HCV, ATL and HIV 2)not applicable

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumio Endo

Organization

Faculty of Life Sciences,
Kumamoto University

Division name

Department of Pediatrics

Zip code


Address

1-1-1 Honjo, Kumamoto 860-8556, Japan

TEL

096-373-5188

Email

fendo@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hitoshi Nakazato

Organization

Kumamoto University

Division name

Department of Pediatrics

Zip code


Address

1-1-1 Honjo, Kumamoto 860-8556, Japan

TEL

096-373-5191

Homepage URL


Email

hnakazat@kuh.kumamoto-u.ac.jp


Sponsor or person

Institute

Department of Pediatrics,
Faculty of Life Sciences,
Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Pediatrics,
Faculty of Life Sciences,
Kumamoto University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

熊本大学附属病院


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2011 Year 04 Month 15 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2015 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 04 Month 20 Day

Last modified on

2017 Year 04 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name