UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000871 |
|---|---|
| Receipt number | R000001048 |
| Scientific Title | Prospective Observational Survey on the Long-Term Effects of the LDL-Apheresis on the Drug Resistant Nephrotic Syndrome |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2012/06/20 20:01:36 |
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Basic information
Public title
Prospective Observational Survey on the Long-Term Effects of the LDL-Apheresis on the Drug Resistant Nephrotic Syndrome
Acronym
Prospective Observational Survey on the Thrapeutic Effects of the LDL-Apheresis on the Drug Resistant Nephrotic Syndrome - POLARIS Survey -
Scientific Title
Prospective Observational Survey on the Long-Term Effects of the LDL-Apheresis on the Drug Resistant Nephrotic Syndrome
Scientific Title:Acronym
Prospective Observational Survey on the Thrapeutic Effects of the LDL-Apheresis on the Drug Resistant Nephrotic Syndrome - POLARIS Survey -
Region
| Japan |
Condition
Condition
Refractory (drug resistant) nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To survey prospectively the long-term effects of the LDL-apheresis therapy on the drug resistant nephritic syndrome as well as the effects of the background factors of patients and the therapeutic conditions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of clinical improvement (total number of the complete remission and the type I incomplete remission)
Key secondary outcomes
Correlation between the rate of clinical improvement and the following factors which could influence the therapeutic effect
1. stage of nephritic syndrome
2. age
3. severity of renal lesion
4. severity of glomerulosclerosis, degree of tubular damage, selectivity index, etc.
5. TAT (blood coagulation marker) level
6. period between the onset of nephritic syndrome and the application of LDL-application
7. frequency of LDL-apheresis
8. dose of steroids used in combination with LDL-apheresis
9. presence or absence of steroid pulse during LDL-apheresis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who satisfy the criteria for refractory nephrotic syndrome (according to the report of the research and surveillance group for specified diseases, progressive renal impairment, the Ministry of Health, Labor and Welfare) and to whom the doctor in charge applied LDL-apheresis therapy on the basis of the guideline of the therapy for focal segmental glomerulosclerosis
Key exclusion criteria
not applicable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Saito |
Organization
Fukuoka University School of Medicine
Division name
Division of Nephrology and Rheumatology
Zip code
Address
7-45-1 Nakakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Muso |
Organization
Kitano Hospital, The Tazuke Kofukai Medical Research Institute
Division name
Division of Nephrology and Dialysis
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan
TEL
06-6312-8824
Homepage URL
polaris2001polaris@yahoo.co.jp
Sponsor or person
Institute
the Japanese Society of Kidney and Lipids Research
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.jskl.org/research.html
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
Completed
Date of protocol fixation
| 2006 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 01 | Day |
Other
Other related information
This survey should be performed in compliance with the Helsinki Declaration and the determined protocol.
Management information
Registered date
| 2007 | Year | 10 | Month | 30 | Day |
Last modified on
| 2012 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
