Actively Recruiting
Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
Led by Children's Hospital of Chongqing Medical University · Updated on 2024-04-19
46
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the efficacy and safety of rituximab(RTX) and mycophenolate mofetile(MMF) in the treatment of children with low-dose steroid-dependent nephrotic syndrome(SDNS).
CONDITIONS
Official Title
Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children with a definite diagnosis of steroid-dependent nephrotic syndrome during relapse treatment
- Age between 3 and 16 years
- Steroid dose of 0.3 mg/kg/day or less
- Cumulative steroid use for 6 months or more
- Ability to swallow tablets
- Guardians understand the trial and its consequences
- Guardians willing to provide informed written consent
You will not qualify if you...
- Diagnosis of secondary nephrotic syndrome such as lupus nephritis, hepatitis B-related nephritis, or purpura nephritis
- Positive anti-neutrophil cytoplasmic antibodies or decreased complement C3 level
- Diagnosis of hereditary nephrotic syndrome
- Use of full dose prednisone (2 mg/kg/day, max 60 mg) for 14 days after relapse without urine protein turning negative
- Estimated glomerular filtration rate below 90 mL/min per 1.73 m² at study entry
- Known allergy to mycophenolate mofetil or rituximab or their excipients
- Refusal to participate in the trial
- Participation in other clinical trials
- Positive hepatitis B or C markers or abnormal liver function tests persistently elevated for 2 weeks
- Severe leukopenia, anemia, or thrombocytopenia at study entry
- History of pancreatitis or gastrointestinal ulcers/bleeding within 6 months
- Congenital or acquired immune deficiency or active infections such as tuberculosis or CMV
- Serious physical or mental illnesses
- History of malignant tumor within 5 years
- Congenital heart disease, arrhythmia, heart failure, or other serious cardiovascular diseases
- Serious infections requiring intravenous antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400014
Actively Recruiting
Research Team
Y
Yang Haiping, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here