Non-corticosteroid immunosuppressive medications for steroid-sensitive nephrotic syndrome in children.
Nicholas G Larkins, Deirdre Hahn, Isaac D Liu...
https://pubmed.ncbi.nlm.nih.gov/39513526Actively Recruiting
Phase 2
Age: 3Years - 16Years
All Genders
ID05843968
Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial
Led by Children's Hospital of Chongqing Medical University · Updated on 2024-04-19
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of two treatments, rituximab and mycophenolate mofetil, for children aged 3 to 16 years with low-dose steroid-dependent nephrotic syndrome (SDNS). SDNS is a common kidney disease in children treated primarily with steroids, but steroid use can cause serious side effects such as growth problems and behavior changes. The study addresses the need to find optimal treatment options with fewer side effects through a controlled trial comparing these two medications. Participants will be randomly assigned to one of two treatment groups. One group will receive two doses of rituximab at 375 mg/m² (up to 500 mg) spaced six months apart, along with preventive medications before infusion to reduce side effects and infections. The other group will take mycophenolate mofetil twice daily at 20-30 mg/kg/day, adjusted to maintain specific blood levels, alongside a tapering steroid regimen over a year. The study will monitor participants over a 12-month period. Children in the trial will undergo regular assessments including monitoring for disease relapse, medication side effects, growth and body mass index changes, quality of life, and treatment costs. The main measure is the relapse-free survival rate over 12 months. Safety will be closely monitored with clinical site oversight to ensure proper treatment adherence and data accuracy. The trial aims to provide clear evidence to guide treatment choices for children with SDNS.
CONDITIONS
Brief Title
Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
Who Can Participate
Age: 3Years - 16Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 3 to 16 years
- Confirmed diagnosis of steroid-dependent nephrotic syndrome during relapse treatment
- Steroid dependent dose less than or equal to 0.3 mg/kg/day
- Cumulative steroid use for 6 months or more
- Ability to swallow tablets
- Guardians understand the trial and provide informed written consent
You will not qualify if you...
- Secondary nephrotic syndrome such as lupus nephritis or hepatitis B-related nephritis
- Positive anti-neutrophil cytoplasmic antibodies (ANCA) or decreased complement C3
- Hereditary nephrotic syndrome diagnosis
- Use of full-dose prednisone (2 mg/kg/day, max 60 mg) for 14 days after relapse without proteinuria remission
- Estimated glomerular filtration rate (eGFR) below 90 mL/min/1.73m² at entry
- Known allergy to rituximab, mycophenolate mofetil, or their excipients
- Participation refusal or involvement in other clinical trials
- Positive hepatitis B or C markers or abnormal liver function sustained for 2 weeks
- Severe leukopenia, anemia, or thrombocytopenia at study entry
- Recent pancreatitis, gastrointestinal ulcers, or bleeding within 6 months
- Congenital or acquired immune deficiency, active tuberculosis, CMV, or other infections
- Serious physical or mental illnesses
- History of malignant tumor within 5 years
- Serious cardiovascular diseases like congenital heart disease or arrhythmia
- Serious infections requiring intravenous antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive either rituximab infusions at 6-month intervals or oral mycophenolate mofetil twice daily with steroid tapering over one year.
Multiple visits for medication administration and monitoring over 12 months
Trial Site Locations
Total: 1 location
1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400014
Actively Recruiting
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Research Team
Y
Yang Haiping, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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