Blinatumomab for CNI-Resistant/Intolerant SRNS in Children (NCT06607991) | Clinical Trial Compass
RecruitingPhase 1
Blinatumomab for CNI-Resistant/Intolerant SRNS in Children
China6 participantsStarted 2024-09-19
Plain-language summary
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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion criteria
✓.Age between 2 and 17 years, regardless of gender. 2.Meet the 2021 KDIGO definition of steroid-resistant nephrotic syndrome (SRNS), and fulfill either of the following:
✓. Have received an adequate dose of calcineurin inhibitors (CNIs) for more than 6 months without achieving at least partial remission.
✓. Or have contraindications to CNI use, including:
✓. Biologic agents: abatacept, ofatumumab, obinutuzumab, rituximab Inadequate response is defined as failure to achieve complete remission after 12 months of therapy or relapse following initial response.
Exclusion criteria
✕. eGFR \< 60 mL/min/1.73 m² (using the modified Bedside Schwartz formula);
✕. Stroke or seizure within 6 months prior to screening, or other active central nervous system disorders;
✕. Genetic nephropathy confirmed by genetic testing;
What they're measuring
1
Effectiveness and safety of Blinatumomab
Timeframe: with 24 weeks of Blinatumomab treatment
Trial details
NCT IDNCT06607991
SponsorThe Children's Hospital of Zhejiang University School of Medicine
✕. Renal biopsy confirming IgA nephropathy, membranous nephropathy, or membranoproliferative glomerulonephritis;
✕. Severe congenital heart disease or history of acute myocardial infarction within 6 months, or severe arrhythmias (e.g., frequent multifocal ventricular or supraventricular tachycardia, ventricular tachycardia), or moderate to large pericardial effusion, severe myocarditis, or unstable vital signs requiring vasopressors to maintain blood pressure;
✕. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with hepatitis B virus (HBV) DNA levels above the normal range; positive for hepatitis C virus (HCV) antibodies with HCV RNA levels above the normal range; or positive for human immunodeficiency virus (HIV) antibodies, syphilis, or cytomegalovirus (CMV) DNA;
✕. Abnormal laboratory values prior to screening: moderate to severe neutropenia (≤1.0×10⁹/L); moderate to severe anemia (hemoglobin ≤90 g/L); thrombocytopenia (≤75×10⁹/L); or liver dysfunction (ALT, AST, or bilirubin greater than 2.5 times the upper limit of normal and persisting for 2 weeks);
✕. Subjects with tumors or other life-threatening diseases prior to screening;