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New treatment option for CNI-resistant Steriod Resistant Nephrotic Syndrome
Official title Blinatumomab for CNI-Resistant/Intolerant SRNS in Children
ClinicalTrials.gov ID: NCT06607991
What this study is testing
What is Blinatumomab Treatment?
Blinatumomab Treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cni-resistant steriod resistant nephrotic syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- \- people must meet all of the following criteria to be included in the study: 1.Age between 2 and 17 years, regardless of gender. 2.Meet the 2021...
- 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: 1) Significant renal impairment, defined as estimated glomerular filtration rate (eGFR) \< 60...
- Conventional immunosuppressive agents: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus...
- Biologic agents: abatacept, ofatumumab, obinutuzumab, rituximab Inadequate response is defined as failure to achieve complete remission after 12...
You likely can't join if
- people who meet any of the following criteria will be excluded from the study:
- 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;
- 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...
See the full eligibility criteria
- \- people must meet all of the following criteria to be included in the study: 1.Age between 2 and 17 years, regardless of gender. 2.Meet the 2021 KDIGO definition of steroid-resistant nephrotic syndrome (SRNS), and...
- 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: 1) Significant renal impairment, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m², or presence of acute kidney injury at the time of diagnosis...
- Conventional immunosuppressive agents: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide
- 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. 3\. Renal biopsy...
- people who meet any of the following criteria will be excluded from the study:
- 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;
- 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...
- 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...
- 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...
- people with tumors or other life-threatening diseases prior to screening;
- Positive blood pregnancy test;
- Participation in other clinical trials within 1 month prior to enrollment;
- Received rituximab or cyclophosphamide therapy within the past 3 months;
- Any other condition deemed by the investigator to be unsuitable for participation;
- Vaccination with live vaccines within 4 weeks prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.