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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011517
Receipt No. 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

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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
Institute Hyogo College of Medicine
Institute
Department

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
URL(English) https://upload.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


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