Rituximab Trial for Pediatric Nephrotic Syndrome
RTX2012
A Multi-center Randomized Controlled Trial of Rituximab for Refractory Nephrotic Syndrome in Children
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 25, 2012
CompletedFirst Posted
Study publicly available on registry
October 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedOctober 29, 2012
October 1, 2012
1.1 years
October 25, 2012
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
steroid-resistant
ACTIVE COMPARATORSteroid-resistant group: n=27 , enroll all for treatment
steroid-dependent-rituximab
ACTIVE COMPARATORsteroid-responsive group: n=38
steroid-dependent-placebo
PLACEBO COMPARATORsteroid-responsive group: n=23
Interventions
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.
Eligibility Criteria
You may qualify if:
- (A)steroid/calcineurin inhibitor resistant nephrotic syndrome
- steroid resistance: no remission after 4 weeks of daily oral corticosteroid (60mg/m2/day)
- calcineurin inhibitor resistance: no remission after 3 months of therapeutic dose administration of cyclosporine and/or tacrolimus
- no remission defined by persistent proteinuria of nephrotic range for the last 3 months
- post-transplant patients were included in the study
- (B)steroid-dependent nephrotic syndrome
- Steroid-dependent patients who had been on various known medications (such as corticosteroids, cyclophosphamide, chlorambucil, calcineurin inhibitors, levamisole ..) continuously for more than 2 years
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Children's Hospital
Seoul, 110-740, South Korea
Related Publications (2)
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.
PMID: 40337980DERIVEDLarkins 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.
PMID: 39513526DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hee Gyung Kang A. Kang, M.D., Ph.D.
Seoul National University Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 25, 2012
First Posted
October 29, 2012
Study Start
August 1, 2012
Primary Completion
September 1, 2013
Study Completion
November 1, 2013
Last Updated
October 29, 2012
Record last verified: 2012-10