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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003227
Receipt No. R000003705
Scientific Title Study of the apheresis therapy.
Date of disclosure of the study information 2010/02/23
Last modified on 2015/10/02

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Basic information
Public title Study of the apheresis therapy.
Acronym The effects of apheresis therapy on renal impairment: APHEREIT Study
Scientific Title Study of the apheresis therapy.
Scientific Title:Acronym The effects of apheresis therapy on renal impairment: APHEREIT Study
Region
Japan

Condition
Condition Diseases on apheresis therapy including renal diseases.
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of apheresis on renal impairment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical improvement, markers of inflammation and oxidative stress, pathological factors including cytokines, proteinuria, renal function, and prognosis
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria The patients on apheresis who agreed with this observational study.
Key exclusion criteria Exclusion criteria: Judged as unsuitable by physician.
Target sample size 50

Research contact person
Name of lead principal investigator
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 1-1 Mukogawa-cho Nishinomiya
TEL 0798-45-6521
Email cherry39@hyo-med.ac.jp

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 1-1, Mukogawa-cho, Nishinomiya
TEL 0798-45-6521
Homepage URL
Email cherry39@hyo-med.ac.jp

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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 23 Day

Related information
URL releasing protocol
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
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 No longer recruiting
Date of protocol fixation
2009 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Factors] Apheresis: methods(TP, Alb, IgG, Fbg etc). Renal impairment: proteinuria, Ccr, uremic toxins, inflammation and oxidative stress etc. Basic disease: antibody etc.
[Evaluation] Activity of the disease, rate of remission, prognosis etc.

Management information
Registered date
2010 Year 02 Month 22 Day
Last modified on
2015 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003705

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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