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Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

StatusRecruiting
PhasePhase 1
Started2024-09-19
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 6, 2025 (before its estimated September 19, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-08-03
Study Status, Oversight, Study Description, Conditions, Eligibility v2
Primary completion date2025-09-19→2026-09-19
Eligibility criteria+678 characters
- Inclusion Criteria: Subjects must meet all of the following [...] he study: 1.Age between 2 and 17 years, regardless of gender; . 2.Meet the 2021 KDIGO 2021 definition of steroid-resistant nephrotic syndrome (SRNS), and havefulfill either of the following: Have received an adequate dose of CNIcalcineurin inhibitors (CNIs) for more than 6 months without achieving at least partial remission; or. Or have contraindications or i intolerance to CNI use, including: 1) Significant renal impairment, withdefined as estimated glomerular filtration rate (eGFR) &lt;< 60 mL/min/1.73 m², or presence of acute kid [...] [...]
Study description+763 characters
[...] ve proteinuria, hypoalbuminemia, hyperlipidemia, and edema. SteroidApproximately 15-20% of pediatric NS cases are classified as steroid-resistant nephrotic syndrome (SRNS), occursa incondition about 15-20% of childrenassociated with NS,poor withprognosis aand poorlimited response to steroidstandard therapytherapies. SRNS can further be complicated by resistance or intolerance to calcineurinCalcineurin inhibitors (CNICNIs), commonlyare frequently used as first-line therapiesimmunosuppressants in SRNS; however, a subset of patients demonstrate resistance to or intolerance of CNIs. Moreover, a pr [...] [...]
2024-12-03
Study Status, Oversight v1
Re-verified, no change to tracked fields
2024-09-19
Original filing
This exploratory clinical trial aims to evaluate the efficacy and safety of Blinatumomab in treating children with calcineurin inhibitor (CNI)-resistant or multidrug-resistant steroid-resistant nephrotic syndrome (SRNS). Eligible participants include pediatric patients aged 2 to 17 years who have either failed to respond to adequate CNI therapy or are resistant to at least two classes of immunosuppressants, including CNIs and biologics. A short course of low-dose Blinatumomab will be administered in an open-label, single-arm, self-controlled trial design. The study seeks to determine whether Blinatumomab can reduce proteinuria and induce clinical remission in this difficult-to-treat population, offering a potential new therapeutic option for children with limited response to conventional therapies.
Trial Details
NCT Number NCT06607991
Lead Sponsor The Children's Hospital of Zhejiang University School of Medicine
Conditions CNI-resistant Steriod Resistant Nephrotic Syndrome, CNI-intolerent, Steriod Resistant Nephrotic Syndrome, Multidrug Resistant Nephrotic Syndrome
Enrollment 6 participants
Start Date 2024-09-19
Primary Completion 2026-09-19 (estimated)
Study Completion 2027-09-18 (estimated)
Updated on ClinicalTrials.gov 2025-08-06