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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000864
Receipt No. 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

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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
Email 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
Email mitarai@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center, Saitama Medical School
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001038

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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