Steroid Dependent Nephrotic Syndrome, Steroid Resistant Nephrotic Syndrome
Conditions
Keywords
rituximab, nephrotic, refractory
Brief summary
Anti-CD20 agent has been proposed as a rescue therapy for refractory nephrotic syndrome(NS) on the basis of favorable clinical observations. Yet the long-term effect on maintaining remission or the likelihood of becoming rituximab-dependent is unclear and the information on the safety profile of rituximab is limited. This trial was designed to investigate the safety and efficacy of Rituximab in children with refractory NS.
Interventions
DRUGRituximab
Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval.
DRUGPlacebo
Sponsors
Seoul National University Childrens Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
(A)steroid/calcineurin inhibitor resistant nephrotic syndrome 1. steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day) 2. calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus 3. no remission defined by persistent proteinuria of nephrotic range for the last 3 months 4. post-transplant patients were included in the study (B)steroid-dependent nephrotic syndrome 1. Steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years 2. definition of dependency: more than two consecutive relapse events in 2 weeks after discontinuation of steroid or calcineurin inhibitor * no improvement in relapsing frequency with calcineurin inhibitor use * unable to continue with calcineurin inhibitor due to side effects * unable to continue with calcineurin inhibitor due to prolonged use (over 2 years) * other conditions in which the clinician considers difficult to control disease with steroids or calcineurin inhibitors only.
Exclusion criteria
* previous rituximab use * secondary nephrotic syndrome * estimated GFR \<60mL/min/1.73m2 or under 50% of age-matched standard GFR * chronic or acute active infection (e.g. hepatitis B,C, herpes, varicella zoster) * prior live vaccine inoculation within 1 month (from the study enrollment) * cardiovascular diseases, pulmonary or pleural diseases * uncontrolled hypertension * leukocytopenia (absolute neutrophil count \<1500/mm3) or thrombocytopenia (\<75000/mm3) * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The remission rate of steroid-resistant nephrotic syndrome patients after rituximab treatment | within 6 months from the initiation of treatment |
| The rate of maintaining remission in steroid-dependent nephrotic syndrome patients | within 6 months from the initiation of treatment versus placebo control |
Countries
South Korea
Contacts
Primary ContactHee Gyung A. Kang, M.D., Ph.D.
Outcome results
None listed