UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011517
Receipt number R000013423
Scientific Title Influence of steroid therapy and LDL apheresis therapy on proteinuria of kidney disease
Date of disclosure of the study information 2013/08/20
Last modified on 2015/06/25 15:03:03

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Basic information

Public title

Influence of steroid therapy and LDL apheresis therapy on proteinuria of kidney disease

Acronym

ITPro study

Scientific Title

Influence of steroid therapy and LDL apheresis therapy on proteinuria of kidney disease

Scientific Title:Acronym

ITPro study

Region

Japan


Condition

Condition

Kidney disease patients with proteinuria

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of influence of steroid therapy and LDL apheresis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Proteinuria (g/dat, g/gCr), renal function(sCr, cystatin C, eGFR, CCr et al), steroid therapy

Key secondary outcomes

Circulating factors related to proteinuria: lipid (LDL, sdLDL et al), inflammation (high-sensitivity CRP, interleukin-6, tumor necrosis factor-alpha, Th1/Th2 et al), oxidative stress (urine L-type fatty acid binding protein, soluble urokinase receptor, malondialdehyde, ST2S, CLCF-1, hemopexin, vitronectin, Flt-1, PAI-1, MCP-1 et al.)


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

3 years-old <=

Age-upper limit

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Kidney disease patients with proteinuria

Key exclusion criteria

malignancy, and hematological, hepatic, and heart diseases

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takeshi Nakanishi

Organization

Hyogo College of Medicine

Division name

Dep Internal Medicine, Div Kidney and Dialysis

Zip code


Address

1-1 Mukogawa-cho, Nishinomiya, Hyogo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Yukiko Hasuike

Organization

Hyogo College of Medicine

Division name

Department of Internal Medicine, Division of Kidney and Dialysis

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hyogo College of Medicine

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


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

兵庫医科大学病院


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 20 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


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

Open public recruiting

Date of protocol fixation

2013 Year 08 Month 12 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Investigation of influence of steroid therapy and LDL apheresis on proteinuria


Management information

Registered date

2013 Year 08 Month 19 Day

Last modified on

2015 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013423


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name