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RECRUITING

NCT05843968

PHASE2

Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome

Sponsor: Children's Hospital of Chongqing Medical University

View on ClinicalTrials.gov

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).

Official title: Rituximab Versus Mycophenolate Mofetil in Children With Steriod-dependent Nephrotic Syndrome: A Single-center, Randomized Controlled Trial

Key Details

Gender

All

Age Range

3 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-01-29

Completion Date

2026-07-01

Last Updated

2024-04-19

Healthy Volunteers

Conditions

Nephrotic Syndrome in Children

Interventions

DRUG

Rituximab

2 doses of rituximab 375 mg/m\^2(maximum 500mg/day) at 6 months intervals. Half an hour before rituximab infusion: oral acetaminophen 15mg/kg, oral or intramuscular antihistamine, methylprednisolone 2mg/kg IV. Trimethoprim-sulfamethoxazole should be administered orally from the initiation of rituximab therapy until peripheral-blood B cell recovery to prevent pneumocystis infection.

DRUG

Mycophenolate Mofetil

Mycophenolate Mofetil 20-30 mg/kg/day BID,then adjust the dosage of drugs(maximum 2g/day) to maintian the concentration for MPA-AUC is 30-50μg.h/ml. Total duration:1year. Steroids dose:1.5mg/kg(maximum 40mg) qod for 2 weeks and gradually taper by 0.3 mg/kg every 2 weeks

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.

Locations (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China