Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
88 participants
INTERVENTIONAL
2012-08-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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steroid-resistant
Steroid-resistant group: n=27 , enroll all for treatment
Rituximab
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.
steroid-dependent-rituximab
steroid-responsive group: n=38
Rituximab
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.
steroid-dependent-placebo
steroid-responsive group: n=23
Placebo
Interventions
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Rituximab
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.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
1 Year
18 Years
ALL
No
Sponsors
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Seoul National University Childrens Hospital
OTHER
Responsible Party
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Hee Gyung Kang
Associate Professor
Principal Investigators
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Hee Gyung Kang A. Kang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Children's Hospital
Locations
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Seoul National University Children's Hospital
Seoul, , South Korea
Countries
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Central Contacts
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References
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Liu ID, Willis NS, Craig JC, Hodson EM. Interventions for idiopathic steroid-resistant nephrotic syndrome in children. Cochrane Database Syst Rev. 2025 May 8;5(5):CD003594. doi: 10.1002/14651858.CD003594.pub7.
Larkins NG, Hahn D, Liu ID, Willis NS, Craig JC, Hodson EM. Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children. Cochrane Database Syst Rev. 2024 Nov 8;11(11):CD002290. doi: 10.1002/14651858.CD002290.pub6.
Other Identifiers
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RTX-2012
Identifier Type: -
Identifier Source: org_study_id