Nephrotic Syndrome in ChildrenNCT05044169
Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
A study testing Broncho-Vaxom in people with Nephrotic Syndrome in Children, run by Fang Deng.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Nephrotic Syndrome in Children
- What is being tested?
- Broncho-Vaxom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Broncho-Vaxom in Reducing Recurrence in Children With Steroid-sensitive Nephrotic Syndrome: Prospective, Randomized Controlled, Multicenter Clinical Study
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.
Read the 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.
- Conditions
- Nephrotic Syndrome in Children
- Being tested
- Broncho-Vaxom
- Keywords
- relapse, infection
- Medical subject headings
- Recurrence, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho-VaxomDrug
Also called OM-85BV
administration for 6 months after remmission
| Study group | Role | What they receive |
|---|---|---|
| Broncho-Vaxom | Experimental | Intervention Receives: Drug: Broncho-Vaxom |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year relapse-free survival rate
The rate of no relapse within 1 year
Measured: 1-year period after randomization
Secondary outcomes (4)
Time to relapse (days)
Number of days from randomization to occurrence of first relapse
Measured: 1-year period after administration of Broncho-Vaxom therapy
Proportion of patients with a relapse
The proportion of patients with relapse
Measured: 6 months period after administration of Broncho-Vaxom therapy
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.
Measured: 1-year period after administration of Broncho-Vaxom therapy
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.
Measured: 1-year period after administration of Broncho-Vaxom therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fang Deng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fang Deng, Anhui Provincial Children's Hospital
- Investigators
- Fang Deng, PhD.MD., Principal investigator, Anhui Provincial Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044169
- Sponsor's protocol ID
- AnhuiPCH
- Status last verified
- Sep 2021
- First submitted
- 5 Sep 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Broncho-Vaxom in Reducing Recurrence in Children With Steroid-sensitive Nephrotic Syndrome: Prospective, Randomized Controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT05044169
- Acronym / sponsor ID
- AnhuiPCH
- Conditions
- Nephrotic Syndrome in Children
- Keywords
- relapse, infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Fang DengUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Broncho-Vaxom | Experimental | Drug: Broncho-VaxomIntervention |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho-VaxomAlso: OM-85BVadministration for 6 months after remmission | Drug | Broncho-Vaxom |
Primary outcome
1-year relapse-free survival rate
Time frame: 1-year period after randomization
The rate of no relapse within 1 year
4 secondary outcomes
Time to relapse (days)
Time frame: 1-year period after administration of Broncho-Vaxom therapy
Proportion of patients with a relapse
Time frame: 6 months period after administration of Broncho-Vaxom therapy
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.
Time frame: 1-year period after administration of Broncho-Vaxom therapy
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1-year period after administration of Broncho-Vaxom therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Deng, PhD.MD. principal investigator
Anhui Provincial Children's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Broncho-Vaxom in people with Nephrotic Syndrome in Children, run by Fang Deng.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang Deng, PhD.MD. (+86055162237848, dengfang1997@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year relapse-free survival rate (time frame: 1-year period after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.