Comparing Rituximab and Mycophenolate Mofetil for Treating Children with Nephrotic Syndrome
Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial
This study is testing whether rituximab or mycophenolate mofetil works better to treat children aged 3-16 with steroid-dependent nephrotic syndrome.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 3 Years to 16 Years |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Drugs / interventions | Rituximab, prednisone |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT05843968 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of rituximab (RTX) versus mycophenolate mofetil (MMF) in treating children aged 3-16 years with steroid-dependent nephrotic syndrome (SDNS). The study will involve a single-center, randomized controlled design, where eligible participants will be screened and assigned to receive either RTX or MMF. The trial addresses the need for optimal treatment regimens for SDNS, given the significant side effects associated with long-term steroid use. Data will be monitored independently to ensure safety and adherence to the study protocol.
Who should consider this trial
Good fit: Ideal candidates are children aged 3-16 years with a confirmed diagnosis of steroid-dependent nephrotic syndrome who are currently undergoing relapse treatment.
Not a fit: Patients with secondary nephrotic syndrome or those with certain contraindications, such as known allergies to the study medications, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for children suffering from steroid-dependent nephrotic syndrome.
How similar studies have performed: While there have been studies on the effectiveness of rituximab and mycophenolate mofetil, this particular approach in a controlled setting for low-dose SDNS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children with a definite diagnosis of SDNS are included in the study during relapse treatment. * Age 3-16 years. * Steroid dependent dose≤0.3mg/kg/day. * Cumulative steroid use for ≥6 months. * Ability to swallow tablet. * Guardians understand the characteristics and personal consequences of clinical trial. * Guardians willing to give informed written consent. Exclusion Criteria: * Diagnosis of secondary NS, such as secondary to lupus nephritis, hepatitis B-related nephritis, purpura nephritis, etc. * Anti-neutrophil cytoplasmic antibodies(ANCA) positive or complement C3 level decreased. * Diagnosis of hereditary nephrotic syndrome. * Full dose of prednisone (2mg/kg/day, maximum 60mg) are used for 14 days after relapse and urine protein don't turn negative. * Estimated glomerular filtration rate (eGFR) \<90mL/min per 1.73m\^2 at study entry. * Those who with a known allergy to Mycophenolate Mofetil and their excipients or to Rituximab and its excipients. * Those who refuse to participate in the trial. * Those who participate other clinical trials. * Those who with positive HBV serological markers (HBsAg or/and HBeAg or/and HBcAb), HCV positive patients or patients with abnormal liver function (ALT,AST,or bilirubin\>2 or more times the upper limit of the normal range and persistently elevated for 2 weeks). * Severe leukopenia (white blood cells\<3.0×10\^9), severe anemia (hemoglobin\<90g/l), and thrombocytopenia (platelets\<100×10\^9) at study entry. * History of pancreatitis or definite gastrointestinal ulcers and/or gastrointestinal bleeding within 6 months. * Those who with congenital or acquired immune deficiency, or with active tuberculosis, active CMV and other infections. * Those who with other serious physical or mental illnesses. * History of malignant tumor within 5 years. * Those who with congenital heart disease, arrhythmia, heart failure and other serious cardiovascular diseases. * Those who with serious infections requiring intravenous antibiotics.
Where this trial is running
Chongqing, Chongqing Municipality
- Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yang Haiping, Doctor
- Email: oyhp@hospital.cqmu.edu.cn
- Phone: 8618983703661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.