Nephrotic Syndrome in Children Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05588063 -
taVNS for FRNS in Children
|
N/A | |
| Recruiting |
NCT05583942 -
A Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS)
|
N/A | |
| Recruiting |
NCT06125405 -
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
|
Phase 3 | |
| Completed |
NCT04034316 -
Reduce Immunosuppression With Atmp in NS ChildrEn
|
Phase 2 | |
| Completed |
NCT04048161 -
Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome
|
Phase 4 | |
| Recruiting |
NCT06079788 -
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
|
Phase 3 | |
| Enrolling by invitation |
NCT04571658 -
NEPTUNE Match Study
|
||
| Recruiting |
NCT06417320 -
Effect of Sodium-glucose Cotransporter-2 Inhibitors (SGLT-2i) on Proteinuria in Nephrotic Children Older Than 10 Years
|
Phase 4 | |
| Recruiting |
NCT05843968 -
Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Children With Steroid-dependent Nephrotic Syndrome
|
Phase 2 | |
| Recruiting |
NCT05734794 -
Study of Rituximab Monotherapy on Children With New-onset Nephrotic Syndrome: A Randomized Controlled Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06130631 -
Predictors of Steroid Response in Childhood Nephrotic Syndrome
|
||
| Terminated |
NCT03878914 -
Steroid Sensitive Nephrotic Syndrome in Children
|
Phase 4 | |
| Recruiting |
NCT03786263 -
CHILDNEPH The Canadian Childhood Nephrotic Syndrome Study
|
||
| Recruiting |
NCT05772871 -
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
|
Phase 4 | |
| Recruiting |
NCT05505500 -
Interview Study of Adult and Child Patients and Parents of Children With Swelling Due to Nephrotic Syndrome.
|