UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003227 |
|---|---|
| Receipt number | R000003705 |
| Scientific Title | Study of the apheresis therapy. |
| Date of disclosure of the study information | 2010/02/23 |
| Last modified on | 2015/10/02 16:47:27 |
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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
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
cherry39@hyo-med.ac.jp
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
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
Value
https://center6.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 |
