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Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

Primary Purpose

Nephrotic Syndrome in Children

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Broncho-Vaxom
Sponsored by
Fang Deng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrotic Syndrome in Children focused on measuring relapse, infection

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    5. 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. History of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia，or poorly controlled hypertension 5. Presence or history of autoimmune diseases or vascular purpura. 6. Presence or history of malignant tumor 7. History of organ transplantation (excluding corneal and hair transplants). 8. Patients with a known allergy to steroid and their excipients or to Broncho-Vaxom 9. Assessed to be unfit for participation by the investigators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Broncho-Vaxom

    Arm Description

    Intervention

    Outcomes

    Primary Outcome Measures

    1-year relapse-free survival rate
    The rate of no relapse within 1 year

    Secondary Outcome Measures

    Time to relapse (days)
    Number of days from randomization to occurrence of first relapse
    Proportion of patients with a relapse
    The proportion of patients with relapse
    The effect of Broncho-Vaxom on peripheral blood B cell subsets and T cell subsets to highlight biomarkers useful for monitoring response to Broncho-Vaxom treatment.
    Using fluorescence-activated cell sorting (FACS), peripheral blood B cell subsets and T cell subsets will be measured as at baseline, before and after infusion of Broncho-Vaxom at 3,6,9,12 months, and when relapse.
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    It is a binary variable (1/0). The varibale would be setted as "1" if any adverse events occours including cough, diarrhea, abdominal pain, skin rashes, hives, swelling, eyelid/facial swelling, nausea, vomiting, systemic skin rashes, itching, fatigue, peripheral swelling, angioedema, etc. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events.

    Full Information

    First Posted
    September 5, 2021
    Last Updated
    September 5, 2021
    Sponsor
    Fang Deng
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05044169
    Brief Title
    Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
    Official Title
    Efficacy and Safety of Broncho-Vaxom in Reducing Recurrence in Children With Steroid-sensitive Nephrotic Syndrome: Prospective, Randomized Controlled, Multicenter Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Fang Deng

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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 Broncho-Vaxom (administration for 6 months) may reduce the risk of subsequent relapse during 12-month of follow-up.
    Detailed Description
    NS is the most frequent glomerular disease in children. Between 80% and 90% of children with steroid-sensitive nephrotic syndrome (SSNS) will relapse following an initial response to corticosteroids. Half of these children will experience frequent relapses (FRNS) or become steroid-dependent (SDNS). Infection is the most common and serious complication in children with NS. More than 80% patients had infections before relapse. The results of multiple observational studies and randomized control trials have shown that Broncho-Vaxom, a lysate of 8 common bacterial respiratory pathogens, is safe and effective to prevent infections in children. To the investigators' knowledge, Broncho-Vaxom has never been investigated for the initial episode of NS with the aim to reduce the subsequent risk of relapse that is a major concern in the management of children with NS. Children aged 1-18 years with the first episode of the SSNS will be treated with Broncho-Vaxom for 6 months. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nephrotic Syndrome in Children
    Keywords
    relapse, infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    83 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Broncho-Vaxom
    Arm Type
    Experimental
    Arm Description
    Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Broncho-Vaxom
    Other Intervention Name(s)
    OM-85BV
    Intervention Description
    administration for 6 months after remmission
    Primary Outcome Measure Information:
    Title
    1-year relapse-free survival rate
    Description
    The rate of no relapse within 1 year
    Time Frame
    1-year period after randomization
    Secondary Outcome Measure Information:
    Title
    Time to relapse (days)
    Description
    Number of days from randomization to occurrence of first relapse
    Time Frame
    1-year period after administration of Broncho-Vaxom therapy
    Title
    Proportion of patients with a relapse
    Description
    The proportion of patients with relapse
    Time Frame
    6 months period after administration of Broncho-Vaxom therapy
    Title
    The effect of Broncho-Vaxom on peripheral blood B cell subsets and T cell subsets to highlight biomarkers useful for monitoring response to Broncho-Vaxom treatment.
    Description
    Using fluorescence-activated cell sorting (FACS), peripheral blood B cell subsets and T cell subsets will be measured as at baseline, before and after infusion of Broncho-Vaxom at 3,6,9,12 months, and when relapse.
    Time Frame
    1-year period after administration of Broncho-Vaxom therapy
    Title
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Description
    It is a binary variable (1/0). The varibale would be setted as "1" if any adverse events occours including cough, diarrhea, abdominal pain, skin rashes, hives, swelling, eyelid/facial swelling, nausea, vomiting, systemic skin rashes, itching, fatigue, peripheral swelling, angioedema, etc. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events.
    Time Frame
    1-year period after administration of Broncho-Vaxom therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.No immunosuppressive agents have been used within 3 months of enrollment, except for the use of corticosteroid to treat nephrotic syndrome. 5. 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. History of angina pectoris, cardiac failure, myocardial infarction, or serious arrhythmia，or poorly controlled hypertension 5. Presence or history of autoimmune diseases or vascular purpura. 6. Presence or history of malignant tumor 7. History of organ transplantation (excluding corneal and hair transplants). 8. Patients with a known allergy to steroid and their excipients or to Broncho-Vaxom 9. Assessed to be unfit for participation by the investigators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fang Deng, PhD.MD.
    Phone
    +86055162237848
    Email
    dengfang1997@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fang Deng, PhD.MD.
    Organizational Affiliation
    Anhui Provincial Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome

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