Prospective randomized trial to establish the optimal treatment regimen of rituximab for adult patients with steroid dependent and frequent-relapsing or steroid resistant nephrotic syndrome.
Phase 4
Recruiting
- Conditions
- ephrotic syndrome
- Registration Number
- JPRN-UMIN000019844
- Lead Sponsor
- Osaka General Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of relapse (study period:5-7 years)
- Secondary Outcome Measures
Name Time Method 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)