The prospective multi-center study on effectiveness of LDL-apheresis for FSGS with steroid-resistant nephrotic syndrome

UMIN ID: UMIN000000864

Registered date:01/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: FSGS with steroid-resistant nephrotic syndrome
• Date of first enrollment: 2007/07/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Treatment with LDL-A
Treatment with conventional treatment using steroid, immune-suppressing agents, and other drugs

Outcome(s)

• Primary Outcome: 1. Rate of remission from nephrotic syndrome 2. Duration from start of treatment to remission
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Saitama Medical Center, Saitama Medical School
• Source(s) of Monetary Support: None