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

NCT04783675 | Completed Phase 2

• 1 other identifier: RTXFIRPedINS
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Steroid-Sensitive Nephrotic Syndrome

Outcome Measures

Primary Outcomes (1)

• 1-year relapse-free survival rate

  The rate of no relapse within 1 year

  1-year period after randomization

Secondary Outcomes (5)

• Time to relapse (days)

  1-year period after administration of rituximab therapy

• Proportion of patients with a relapse

  6 months period after administration of rituximab therapy

• B-Cell Recovery Time

  1-year period after administration of rituximab therapy

• The effect of rituximab on peripheral blood B cell subsets and T cell subsets to highlight biomarkers useful for monitoring response to rituximab treatment.

  1-year period after administration of rituximab therapy

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1-year period after administration of rituximab therapy

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

Drug: Rituximab

Interventions

Rituximab DRUG

Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission

Intervention/treatment

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome
• \. Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry.
• \. Remission at study entry
• CD20 positive cells in peripheral blood ≥1% total lymphocytes
• No immunosuppressive agents have been used within 3 months of enrollment, except for the use of corticosteroid to treat nephrotic syndrome.
• \. 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.

You may not qualify if:

• Diagnosis of secondary NS
• 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.
• \. 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
• \. Receipt of a live vaccine within 4 weeks before enrollment.
• \. Prior receipt of monoclonal antibodies of any type
• \. History of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia，or poorly controlled hypertension
• \. Presence or history of autoimmune diseases or vascular purpura.
• \. Presence or history of malignant tumor
• \. History of organ transplantation (excluding corneal and hair transplants).
• \. 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
• \. Assessed to be unfit for participation by the investigators

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Children's Hospital of Nanjing Medical University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Anhui Provincial Children's Hospital: collaborator
• Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital: collaborator
• The first affiliated hospital of Zhongshan university: collaborator
• Shandong Provincial Hospital: collaborator
• Xuzhou Children Hospital: collaborator

Study Sites (8)

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Location

Children's Hospital Affiliated to Zhengzhou University/Henan Children's Hospital

Zhengzhou, Henan, China

Location

Wuhan Children's Hospital,Tongji Medical College, Huazhong University of Science and Technology.

Wuhan, Hubei, China

Location

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital of Zhongshan University

Guanzhou, China

Location

Shandong Provincial Hospital Affiliated to Shandong University

Shandong, China

Location

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

Xuzhou Children's Hospital

Xuzhou, China

Location

Related Publications (1)

• Liu J, Shen Q, Xie L, Wang J, Li Y, Chen J, Fang X, Tang X, Qian B, Xu H. Protocol for an open-label, single-arm, multicentre clinical study to evaluate the efficacy and safety of rituximab in the first episode of paediatric idiopathic nephrotic syndrome. BMJ Open. 2022 Oct 12;12(10):e064216. doi: 10.1136/bmjopen-2022-064216.

  PMID: 36223961 DERIVED

MeSH Terms

Conditions

Nephrotic Syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Rituximab

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 5, 2021
• Study Start: April 13, 2021
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When the article has been published with no end date
• Access Criteria: Requests for access to data from the RTXFIRPedINS trial should be addressed to the corresponding author at hxu@shmu.edu.cn. The individual participant data collected during the trial (including the data dictionary) will be available, after de-identification. All proposals requesting data access will need to have a research plan and specify how the data will be used, and all proposals will need the approval of the trial coinvestigator team (or individual(s) subsequently delegated this responsibility) before data release.

Locations

CN (8)