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

NCT05044169 | Unknown DMC

• 1 other identifier: AnhuiPCH
• Study Type: interventional
• Target: 83
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nephrotic Syndrome in Children

Keywords

relapse; infection

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 (4)

• Time to relapse (days)

  1-year period after administration of Broncho-Vaxom therapy

• Proportion of patients with a relapse

  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.

  1-year period after administration of Broncho-Vaxom therapy

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

  1-year period after administration of Broncho-Vaxom therapy

Study Arms (1)

Broncho-Vaxom

EXPERIMENTAL

Intervention

Drug: Broncho-Vaxom

Interventions

Broncho-Vaxom DRUG

administration for 6 months after remmission

Also known as: OM-85BV

Broncho-Vaxom

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

Sponsors & Collaborators

• Fang Deng: lead

MeSH Terms

Conditions

Recurrence; Infections

Interventions

Broncho-Vaxom

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fang Deng, PhD.MD.

  Anhui Provincial Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Deng, PhD.MD.

CONTACT

+86055162237848; dengfang1997@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 14, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 14, 2021

Record last verified: 2021-09