Nephrotic syndrome
Conditions
Interventions
Group A: single dose of rituximab of 375mg/m2 (maximum 500mg) followed by additional single dose every 6 months. Study period is 5 (minimum)-7 (maximum) years.
Group B: double doses of rituximab foll
Sponsors
Osaka General Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who have developed nephrotic syndrome in 18 years old or younger and have been dependent to steroid alone or in combination with calcineurin inhibitors. 2)Patients who have developed nephrotic syndrome in 19 years old or older and have been dependent or resistant to steroid alone or in combination with calcineurin inhibitors and have been complicated with adverse effect of these drugs (eg. diabetes, morbid fracture). 3)Patients diagnosed by renal biopsy as having minimal change disease or focal segmental glomerulosclerosis. 4)Patients who are at least 20 years old when they gave informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients diagnosed by renal biopsy as having any pathology other than minimal change disease or focal segmental glomerulosclerosis. 2)Patients with malignant disease or hematological disease. 3)Patients who are or may be pregnant, brest-feeding or hope to be pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of relapse (study period:5-7 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Duration of complete remission 2)Adverse effect (infusion reaction, anaphylaxis, infectious disease, progressive multifocal leukoencephalopathy, exacerbation of hepatitis and fulminant hepatitis by hepatitis B virus reactivation, skin or mucous membrane symptom, interstitial pneumonia, gastrointestinal perforation or obstruction) | — |
Countries
Japan
Contacts
Public ContactTerumasa Hayashi
Osaka General Medical Center Kidney Disease and Hypertension
Outcome results
None listed