Actively Recruiting

Phase 1
Age: 2Years - 17Years
All Genders
ID06607991

Study of Blinatumomab for the Treatment of Calcineurin Inhibitor-Resistant or Intolerant Steroid-Resistant Nephrotic Syndrome 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

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of Blinatumomab in children aged 2 to 17 years who have a difficult-to-treat form of steroid-resistant nephrotic syndrome (SRNS). These children either do not respond to calcineurin inhibitors (CNIs) or are resistant to multiple immunosuppressive treatments, including biologics. SRNS is characterized by heavy protein loss in urine and is linked to poor outcomes with limited treatment options. Participants will receive two short courses of low-dose Blinatumomab administered intravenously. Each course lasts 5 days, with the second course starting three weeks after the first. This open-label, single-arm study will enroll six children to assess whether this treatment can reduce proteinuria and induce remission by targeting specific immune cells. Throughout the study, researchers will monitor protein levels in urine, kidney function, safety, and immune markers over 24 to 52 weeks. Participants will undergo clinical assessments and laboratory tests to evaluate treatment effects and side effects. The study aims to gather preliminary data on Blinatumomab as a potential new therapy for children with resistant SRNS.

CONDITIONS

Brief Title

Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

Who Can Participate

Age: 2Years - 17Years
All Genders

Eligibility Criteria

Eligible

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 inadequate response to calcineurin inhibitors (CNIs) after more than 6 months or contraindications to CNIs such as significant kidney impairment or severe hypertension
  • Inadequate response or relapse after treatment with at least two immunosuppressive agents including CNIs and biologics
  • Kidney biopsy confirming minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS)
  • Written informed consent provided by participant or legal guardian
Not Eligible

You will not qualify if you...

  • Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m²
  • Stroke, seizure, or active central nervous system disorders within 6 months prior to screening
  • Genetic nephropathy confirmed by testing
  • Kidney biopsy showing IgA nephropathy, membranous nephropathy, or membranoproliferative glomerulonephritis
  • Severe heart disease or recent acute myocardial infarction, severe arrhythmias, myocarditis, or unstable vital signs
  • Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus with high viral loads
  • Abnormal blood counts or liver function tests prior to screening
  • Tumors or other life-threatening diseases before screening
  • Positive pregnancy test
  • Participation in other clinical trials within 1 month prior
  • Rituximab or cyclophosphamide treatment within past 3 months
  • Any condition deemed unsuitable by the investigator
  • Live vaccination within 4 weeks prior to screening

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 weeks

Participants receive two 5-day cycles of Blinatumomab administered intravenously to treat steroid-resistant nephrotic syndrome that is resistant or intolerant to calcineurin inhibitors.

2 short treatment cycles spaced 2 weeks apart with additional monitoring visits

Follow-up

Duration - Up to 46 weeks

Participants are monitored for long-term efficacy, safety, and changes in immunologic markers and renal function after treatment.

Regular visits for up to 46 weeks after treatment

Trial Site Locations

Total: 1 location

1

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

J

Jianhua Mao, PhD, MD

X

Xiaojing Zhang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial