Actively Recruiting
Blinatumomab for CNI-Resistant/Intolerant SRNS in Children
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2025-08-06
6
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blinatumomab for CNI-Resistant/Intolerant SRNS in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 2 and 17 years, any gender
- Diagnosis of steroid-resistant nephrotic syndrome (SRNS) according to 2021 KDIGO criteria
- Either no remission after at least 6 months of adequate calcineurin inhibitor (CNI) therapy or contraindications to CNI use
- Contraindications include significant kidney impairment (eGFR < 60 mL/min/1.73 m), acute kidney injury, severe tubular injury on biopsy, elevated urinary markers, abnormal glucose tolerance, severe uncontrolled hypertension, drug interactions, or allergy to CNIs
- Inadequate response or relapse after treatment with at least two immunosuppressive agents including CNIs and biologics
- Kidney biopsy confirms minimal change disease or focal segmental glomerulosclerosis
- Written informed consent from participant or legal guardian
You will not qualify if you...
- eGFR below 60 mL/min/1.73 m
- Stroke, seizure, or other active central nervous system disorders within 6 months prior
- Confirmed genetic nephropathy
- Kidney biopsy showing IgA nephropathy, membranous nephropathy, or membranoproliferative glomerulonephritis
- Severe congenital heart disease, recent heart attack, severe arrhythmias, moderate to large pericardial effusion, severe myocarditis, or unstable vital signs needing vasopressors
- Positive for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with abnormal viral levels
- Moderate to severe neutropenia, anemia, thrombocytopenia, or liver dysfunction
- Presence of tumors or other life-threatening diseases
- Positive pregnancy test
- Participation in other clinical trials within 1 month
- Rituximab or cyclophosphamide treatment within past 3 months
- Any condition deemed unsuitable by investigator
- Vaccination with live vaccines within 4 weeks prior to screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jianhua Mao, PhD, MD
CONTACT
X
Xiaojing Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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