NCT05843968 Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
| NCT ID | NCT05843968 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Children's Hospital of Chongqing Medical University |
| Condition | Nephrotic Syndrome in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2023-01-29 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 46 participants in total. It began in 2023-01-29 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05843968 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 16 Years, studying Nephrotic Syndrome in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05843968 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05843968 currently recruiting?
Yes, NCT05843968 is actively recruiting participants. Contact the research team at oyhp@hospital.cqmu.edu.cn for enrollment information.
Where is the NCT05843968 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT05843968 clinical trial?
NCT05843968 is sponsored by Children's Hospital of Chongqing Medical University. The trial plans to enroll 46 participants.