UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000864 |
|---|---|
| Receipt number | R000001038 |
| Scientific Title | The prospective multi-center study on effectiveness of LDL-apheresis for FSGS with steroid-resistant nephrotic syndrome |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2015/02/22 16:21:15 |
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Basic information
Public title
The prospective multi-center study on effectiveness of LDL-apheresis for FSGS with steroid-resistant nephrotic syndrome
Acronym
The study on effectiveness of LDL-apheresis (LDL-A) for FSGS
Scientific Title
The prospective multi-center study on effectiveness of LDL-apheresis for FSGS with steroid-resistant nephrotic syndrome
Scientific Title:Acronym
The study on effectiveness of LDL-apheresis (LDL-A) for FSGS
Region
| Japan |
Condition
Condition
FSGS with steroid-resistant nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify effectiveness of LDL-A for FSGS with steroid-resistant nephrotic syndrome by the prospective randomized control study, and to investigate correlation between clinical effect and change of podocyte function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Rate of remission from nephrotic syndrome
2. Duration from start of treatment to remission
Key secondary outcomes
1. Change of markers of renal function
2. Frequency of recurrence or worsening of nephrotic syndrome after remission
3. Total dose of each drug
4. Frequency of complication derived from drug use
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Treatment with LDL-A
Interventions/Control_2
Treatment with conventional treatment using steroid, immune-suppressing agents, and other drugs
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 16 years old who satisfy all of the following terms.
1. Definitively diagnosed as a nephrotic syndrome.
2. Serum total cholesterol>250mg/dL.
3. Diagnosed as a FSGS by renal biopsy.
4. Resistant to steroid treatment.
5. No experience of kidney transplantation.
Key exclusion criteria
Patients coincident with at least one of the following terms should be excluded.
1. Patient for whom anticoagulant agents are contraindicated.
2. LDL-A is inapplicable because of severe heart failure, acute myocardial infarction, severe arythmia, acute stroke, or severe uncontrolable hypertension or hypotension.
3. Ratio of extracorporeal circulation in LDL-A over whole blood volume is too large. Especially, patient with body weight<40kg.
4. Patient with allergy or risk of allergy.
5. Patient with thrombus (stroke, myocardial infarction, or thrombophlebitis) or risk of thrombosis.
6. Patient with disease in which cyclosporin A, cyclophosphamide, or other immune-suppressing agents are contraindicated.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mitarai |
Organization
Saitama Medical Center, Saitama Medical School
Division name
Fourth Department of Internal Medicine
Zip code
Address
1981 Tsujido-machi Kamoda, Kawagoe-shi, Saitama 350-8550, Japan
TEL
049-228-3604
mitarai@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Mitarai |
Organization
Saitama Medical Center, Saitama Medical School
Division name
Fourth Department of Internal Medicine
Zip code
Address
1981 Tsujido-machi Kamoda, Kawagoe-shi, Saitama 350-8550, Japan
TEL
049-228-3604
Homepage URL
mitarai@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical School
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In order to evaluate the efficacy of LDL-apheresis for adult patients with steroid-resistant nephrotic syndrome (NS) whose biopsy finding indicate as having FGGS, we performed a prospective randomized multicenter trial. Only five patients were assigned to Group A (treated with LDL-apheresis) and three patients in Group D (immunosuppressive drug therapy). Then it was difficult to draw any conclusion. However, three of five in Group L, and one in Group D became remission(CR and ICR-I). We evaluated urinary excretion of podocalyxin, and they decrease after remission of NS. We also evaluate the effect of serum from patients on the expression of nephrin using cultured podocyte. The expression of nephrin were elevated after remission of nephrotic syndrome. (The 57th Annual Meeting of Japanese Society Nephrology)
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
| 2007 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 10 | Month | 24 | Day |
Last modified on
| 2015 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001038
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