Nephrotic Syndrome in Children Clinical Trial
Official title:
Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial
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).
Status | Recruiting |
Enrollment | 46 |
Est. completion date | July 1, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 16 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Chongqing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 12-month relapse-free survival rate | The rate of no relapse within 12 months. | 12 months | |
Secondary | 6-month relapse-free survival | Relapse-free survival within 6 months. | 6 months | |
Secondary | 6-month relapse-free survival rate | The rate of no relapse within 6 months. | 6 months | |
Secondary | 12-month relapse-free survival | Relapse-free survival within 12 months. | 12 months | |
Secondary | Proportion of frequent relapses | The proportion of frequent relapses.Frequent relapsing NS:=2 relapses per 6 months within 6 months of disease onset or =4 relapses per 12 months in any subsequent 12-month period. | Months 6,12 | |
Secondary | Cumulative steroid dosage | The total dosage of steroid from the beginning to the end of the trial. | 12 months | |
Secondary | Number of relapses within 0-12,0-6, and 7-12 months | Number of relapses within 0-6 months,7-12 months, and total within 0-12 months. | 12 months | |
Secondary | Time of first relapse | The first time to relapse after patients taking part in this study. | 12 months | |
Secondary | Adverse event | It is a binary variable(1/0).The varibale would be setted as "1" if any adverse events occours including obesity, hypertrichosis, psychological disorders,glaucoma,neutropenia,hypogammaglobulinemia, rituximab-related lung injury, fatal hepatitis reactivation, multifocal leukoencephalopathy,severe diarrhea, severe infection. Adverse events graded according to Common Terminology Criteria For Adverse Events (CTCAE v4.0) | 12 months | |
Secondary | Proportion of participants who discontinued steroids | Proportion of participants who discontinued steroids at 12 months | 12 months | |
Secondary | Height standard deviation score(SDS) | SDS of height at 6 and 12 months, absolute and relative changes in SDS from baseline to 12 months. | months 0,6,12 | |
Secondary | Body mass index(BMI) | Weight and height will be combined to report BMI in kg/m^2. BMI at 6 and 12 months, absolute and relative changes in BMI from baseline to 12 months. | Months 0,6,12 | |
Secondary | Quality of life score | The researchers assess the quality of life of the participants useing Pediatric Quality of Life Inventory (PedsQL). | Baseline to 12 months | |
Secondary | Cost of treatment | The researchers calculate their cost during the study. | 12 months |
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