Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent … (NCT05843968) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
China46 participantsStarted 2023-01-29
Plain-language 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).
Who can participate
Age range3 Years – 16 Years
SexALL
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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.
*…
What they're measuring
1
12-month relapse-free survival rate
Timeframe: 12 months
Trial details
NCT IDNCT05843968
SponsorChildren's Hospital of Chongqing Medical University