Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome (NCT05044169) | Clinical Trial Compass
UnknownNot Applicable
Efficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic Syndrome
83 participantsStarted 2021-09
Plain-language 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.
Who can participate
Age range1 Year – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…