Rituximab and methylprednisolone pulse therapy for childhood-onset, complicated, steroid-resistant nephrotic syndrome: a prospective multicenter trial (JSKDC08)
- Conditions
- childhood-onset, complicated, steroid-resistant nephrotic syndrome
- Registration Number
- JPRN-UMIN000014895
- Lead Sponsor
- Japanese Study Group of Kidney Disease in Children
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1.History of nephritic-NS, such as IgA nephropathy prior to assignment or in whom secondary NS is suspected. 2.Patients who have been detected gene abnormality(NPHS2,WT1)or in whom gene abnormality(NPHS2,WT1)is suspected. 3.History of receiving rituximab within 1 years prior to assignment. 4.History of receiving any kinds of monoclonal antibody therapy. 5.Having received a new immunosuppressant within 4 weeks prior to assignment. 6.Patients meeting either one of the following infection: 1)Presence or history of severe infections within 6 months prior to assignment. 2)Presence or history of opportunistic infections within 6 months prior to assignment. 3)Presence of active tuberculosis. 4)Patients with a history of tuberculosis or in whom tuberculosis is suspected. 5)Presence or history of active Hepatitis B or Hepatitis C or hepatitis B virus carrier. 6)Presence of HIV infection. 7.Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the CTCAE v4.0-JCOG. 8.Presence or history of auto-immune diseases or vascular purpura. 9.Presence or history of malignant tumor. 10.History of organ transplantation. 11.History of drug allergies to methylprednisolone, acetaminophen, or d-chlorpheniramine maleate. 12.Uncontrollable hypertension. 13.Deteriorated kidney function, e.g. eGFR<45 mL/min./1.73m2. 14.Having received a live vaccine within 4 weeks prior to assignment. 15.Patients showing either one of the following abnormal clinical laboratory value: 1)WBC <3,000/microL. 2)neutrophil <1,500/microL. 3)PLT <50,000/microL. 4)ALT >2.5 x upper limit of normal value. 5)AST >2.5 x upper limit of normal value. 6)Positive for HBsAg, HBsAb, HBcAb and HCVAb. 7)Positive for HIV antibody. 16. Patients who do not agree with contraception during the study period. 17.Women during pregnancy or breast-feeding. 18.Judged inappropriate for this study by the physicians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete remission rate at month 6
- Secondary Outcome Measures
Name Time Method Time to complete remission, Partial remission rate, CKD rate, Urinary protein to creatinine ratio, Estimated glomerular filtration rate, B cell depletion period