FSGS with steroid-resistant nephrotic syndrome
Conditions
Interventions
Treatment with LDL-A
Treatment with conventional treatment using steroid, immune-suppressing agents, and other drugs
Sponsors
Saitama Medical Center, Saitama Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of remission from nephrotic syndrome 2. Duration from start of treatment to remission | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTetsuya Mitarai
Saitama Medical Center, Saitama Medical School Fourth Department of Internal Medicine
Outcome results
None listed