Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607991
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Blinatumomab for CNI-ResistantIntolerant SRNS in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Study of Blinatumomab for the Treatment of Calcineurin Inhibitor-Resistant or Intolerant Steriod-Resistant Nephrotic Syndrome in Pediatric Patients
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to evaluate the safety and effectiveness of Blinatumomab in treating children with calcineurin inhibitor CNI-resistant or intolerant steriod-resistant nephrotic syndrome SRNS The study will involve administering a short course of low-dose Blinatumomab to pediatric patients who have not responded to CNI treatments or are unable to tolerate them The goal is to assess whether Blinatumomab can reduce proteinuria and induce remission in these children potentially offering a new therapeutic option for those with limited treatment alternatives
Detailed Description:
Nephrotic syndrome NS in children is characterized by excessive proteinuria hypoalbuminemia hyperlipidemia and edema Steroid-resistant nephrotic syndrome SRNS occurs in about 15-20 of children with NS with a poor response to steroid therapy SRNS can further be complicated by resistance or intolerance to calcineurin inhibitors CNI commonly used as first-line therapies This study aims to explore the use of Blinatumomab a bispecific T-cell engager targeting CD19-positive B cells in treating children with CNI-resistant or intolerant hormone-resistant nephrotic syndrome
The study will follow a single-center open-label design enrolling 6 pediatric patients between the ages of 2 and 17 These patients will receive two 5-day courses of low-dose Blinatumomab administered intravenously Outcomes will include the rate of complete or partial remission of proteinuria safety assessments and immune marker analysis By targeting B cells Blinatumomab may address the underlying immune dysfunction contributing to disease progression in these patients The study will also evaluate the safety of short-term Blinatumomab use in this pediatric population
The study will follow a single-center open-label design enrolling 6 pediatric patients between the ages of 2 and 17 These patients will receive two 5-day courses of low-dose Blinatumomab administered intravenously Outcomes will include the rate of complete or partial remission of proteinuria safety assessments and immune marker analysis By targeting B cells Blinatumomab may address the underlying immune dysfunction contributing to disease progression in these patients The study will also evaluate the safety of short-term Blinatumomab use in this pediatric population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None