Rituximab in the First Episode of Paediatric Nephrotic Syndrome

NCT05850546 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RTXFIRPedINS2
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 3

Brief Summary

The study will be a randomized, open-label trial in children with the initial episode of SSNS and whose state of complete remission after received standard prednisolone, to determine whether rituximab (a single intravenous infusion of 375 mg/m2) would be noninferior to corticosteroid alone in maintaining complete disease remission during 12-month of follow-up.

Conditions

Steroid-Sensitive Nephrotic Syndrome

Keywords

Rituximab; Children; Relapse

Outcome Measures

Primary Outcomes (1)

• 1-year relapse-free survival rate

  The rate of no relapse within 1 year. Relapse definition: recurrence of nephrotic-range proteinuria, urine protein/creatinine ratio ≥2 mg/mg or dipstick ≥3+ on 3 consecutive days in the first morning samples.

  1-year after randomization

Secondary Outcomes (4)

• Time to relapse (days)

  1-year after randomization

• Peripheral blood T cell subsets

  At basline, 1,3,6,9,12 months after randomization

• Peripheral blood B cell subsets

  At basline, 1,3,6,9,12 months after randomization

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  1-year after randomization

Study Arms (2)

Rituximab

EXPERIMENTAL

Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission. The prednisolone at a dose of 2 mg/kg per day (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for the next 6 weeks; therapy is then discontinued.

Drug: Rituximab; Drug: Corticosteroid

Routine Therapy

OTHER

The prednisolone at a dose of 2 mg/kg per day (maximum 60 mg in single or divided doses) for 6 weeks, followed by 1.5 mg/kg (maximum 40 mg) as a single morning dose on alternate days for the next 6 weeks; therapy is then discontinued.

Drug: Corticosteroid

Interventions

Rituximab DRUG

Rituximab 375 mg/m2 added to guideline-recommended corticosteroid therapy

Also known as: rituximab biosimilar (HANLIKANG®, Shanghai Henlius Biotech, Inc. China)

Rituximab

Corticosteroid DRUG

guideline-recommended corticosteroid therapy

Also known as: prednisolone/prednisone

Rituximab; Routine Therapy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children between 1 and 18 years with Steroid-Sensitive Nephrotic Syndrome (nephrotic-range proteinuria and either hypoalbuminemia or edema when albumin level is not available)
• Estimated glomerular filtration rate (eGFR) ≥90 ml/min per 1.73 m2 at study entry
• Remission at study entry
• the cluster of differentiation antigen 20 (CD20) positive cells in peripheral blood ≥1% total lymphocytes
• No immunosuppressive agents have been used within 3 months of enrolment, except for the use of corticosteroid to treat nephrotic syndrome
• Provision of consent by a legal representative using a document approved by the institutional review board after receiving an adequate explanation of this clinical trial. For children ages 8-18, 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 laboratories
• 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; Alanine aminotransferase or aspartate aminotransferase \> 2.5× upper limit of normal value
• Presence of severe or chronic infections within 6 months before assignment: tuberculosis or in whom tuberculosis is suspected; Epstein-Barr virus or cytomegalovirus; hepatitis B or hepatitis C or hepatitis B virus carrier, human immunodeficiency virus or other active viral infections
• Live vaccination within last month
• Patients with poorly controlled hypertension
• Patients with severe brain, heart, liver, and other important organs, as well as blood and endocrine system diseases
• Presence or history of autoimmune diseases, primary immunodeficiency, or tumor
• Patients with a known allergy to Rituximab and its excipients
• Assessed to be unfit for participation by the investigators (patients highly likely to be lost to follow-up or provide inaccurate data, for example, patients with alcohol or other substance misuse disorders, and patients with psychological disorders)

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Shanghai Shen Kang Hospital Development Center: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai Children's Medical Center: collaborator
• Shanghai Children's Hospital: collaborator

Study Sites (3)

Children's hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

Shanghai's Children's Medical Center

Shanghai, Shanghai Municipality, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 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 RESULT

MeSH Terms

Conditions

Nephrotic Syndrome; Recurrence

Interventions

Rituximab; Adrenal Cortex Hormones; Prednisolone; Prednisone

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Study Officials

• Qian Shen

  Children's Hospital of Fudan University

  STUDY CHAIR

Central Study Contacts

Qian Shen

CONTACT

+8602164932827; shenqian@shmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

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 RTXFIRPedINS2 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 (3)