Childhood-onset, complicated, frequently relapsing nephrotic syndrome or steroid-dependent nephrotic syndrome
Conditions
Interventions
Rituximab and mycophenolate mofetil
rituximab and mycophenolate mofetil placebo
Sponsors
Japanese Study Group of Kidney Disease in Children
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Diagnosed as idiopathic nephrotic syndrome (INS) according to the ISKDC criteria. 2.The first onset of INS is between 1 - 18 years of age, and 2 years of age or older at assignment. 3.Patients meeting either one of the following criteria: 1) Diagnosed with frequent relapse or steroid dependence and once again diagnosed with frequent relapse or steroid dependence after completion of immunosuppressive drug therapy (cyclosporine, cyclophosphamide, or mizoribine, etc.). 2) Diagnosed with frequent relapse or steroid dependence and once again diagnosed with frequent relapse or steroid dependence during immunosuppressive drug therapy (cyclosporine, cyclophosphamide, or mizoribine, etc.). 3) Diagnosed with steroid resistance following the onset of INS anf diagnosed with frequent relapse or steroid dependence during or after the completion of immunosuppressive drug therapy (cyclosporine alone or combination of cyclosporine and methylprednisolone, etc.). 4.Patients with records of nearest preceding 3 relapses. 5.Patients in whom steroid sensitivity is observed during treatment of relapse immediately prior to assignment. 6.Patients in whom 5/microL or more CD20-positive cells are observed in the peripheral blood. 7.Patients who can be hospitalized overnight on the first day of rituximab administration. 8.Written informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients who have been diagnosed with nephritic-NS, such as IgA nephropathy prior to assignment or in whom secondary NS is suspected. 2.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. 3.Presence or history of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia (findings observed under Grade 4 of the CTCAE v4.0-JCOG. 4.Presence or history of auto-immune diseases or vascular purpura. 5.Presence or history of malignant tumor. 6.History of organ transplantation. 7.History of drug allergies to methylprednisolone, acetaminophen, or d-chlorpheniramine maleate. 8.Uncontrollable hypertension. 9.Deteriorated kidney function, e.g. estimated GFR<60 mL/min./1.73m2. 10.Having received a live vaccine within 4 weeks prior to enrollment. 11.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 HBs antigen, HBs antibody, HBc antibody and HCV antibody. 7)Positive for HIV antibody. 12.Patients who do not agree with contraception during the study period. 13.Women during pregnancy or breast-feeding. 14.Judged inap.propriate for this study by the physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free period, Time to SDNS, Time to FRNS, Time to SRNS, B cell depletion period, Daily steroid dose | — |
Countries
Japan
Contacts
Public ContactMayumi Sako
National Center for Child Health and Development Division for Clinical Trials
Outcome results
None listed