Efficacy and Safety of Rituximab in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

• Status: Recruiting
• Trial end date: 2023-05-24
• Target enrollment: 0
• Participant gender: All

Summary

The main objective is to demonstrate, from the initial episode of nephrotic syndrome (NS) in children with standard prednisolone treatment, once complete remission has occurred, that the use of Rituximab (a single intravenous infusion of 375 mg/m2) may reduce the risk of subsequent relapse during 12-month of follow-up.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: Anhui Provincial Children's Hospital; Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital; Children's Hospital of Nanjing Medical University; Henan Provincial People's Hospital; Shanghai Children's Hospital; The Children's Hospital of Zhejiang University School of Medicine; Wuhan Union Hospital, China; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• 1. Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome

• 2. Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.

• 3. Remission at study entry

• 4.CD20 positive cells in peripheral blood ≥1% total lymphocytes

• 5.No immunosuppressive agents have been used within 3 months of enrollment, except for the use of corticosteroid to treat nephrotic syndrome.

• 6. Provision of consent by a legal representative (parents or legal guardians) using a document approved by the institutional review board after receiving an adequate explanation regarding the implementation of this clinical trial. For children/youth ages 10-18, written assent is required using age-appropriate and background-appropriate documents.

Exclusion Criteria:

• 1.Diagnosis of secondary NS

• 2.Patients showing one of the following abnormal clinical laboratory values:

leukopenia (white blood cell count ≤3.0*109/L); moderate and severe anemia (hemoglobin <9.0g/dL); thrombocytopenia (platelet count <100*1012/ L); positivity of autoimmunity tests (ANA, Anti DNA antibody, ANCA) or reduced C3 levels; Positive for hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody ; Positive for HIV antibody; Alanine aminotransferase (ALT) > 2.5× upper limit of normal value. Aspartate aminotransferase (AST) > 2.5× upper limit of normal value.

• 3. Presence or history of severe or opportunistic infections within 6 months before assignment; Presence of active tuberculosis or with a history of tuberculosis or in whom tuberculosis is suspected; Presence or history of chronic active infections such as Epstein-Barr virus and CMV virus; presence or history of active hepatitis B or hepatitis C or hepatitis B virus carrier. Presence of human immunodeficiency virus (HIV) infection or other active viral infections

• 4. Receipt of a live vaccine within 4 weeks before enrollment.

• 5. Prior receipt of monoclonal antibodies of any type

• 6. History of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia，or poorly controlled hypertension

• 7. Presence or history of autoimmune diseases or vascular purpura.

• 8. Presence or history of malignant tumor

• 9. History of organ transplantation (excluding corneal and hair transplants).

• 10. Patients with a known allergy to steroid and their excipients or to Rituximab and its excipients or to acetaminophen and its excipients or to cetirizine and its excipients or to the protein of murine origin

• 11. Assessed to be unfit for participation by the investigators