Actively Recruiting
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-08-21
20
Participants Needed
1
Research Sites
203 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.
CONDITIONS
Official Title
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sensitive but frequent relapses or steroid-dependent nephrotic syndrome
- Age between 2 and 18 years old
- Normal renal function with estimated glomerular filtration rate 9 ml/min/1.73m2
- Morning urine protein less than 1+ or urine protein-creatinine ratio less than 0.2 g/g (20 mg/mmol) for 3 consecutive days at enrollment
- No use of rituximab within 6 months prior to enrollment
- No use of tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide within 3 months prior to enrollment
- No use of ACTH within 3 months prior to enrollment
You will not qualify if you...
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia
- Leukopenia with white blood cells count 6 3.0 x 10^9/L
- Moderate to severe anemia with hemoglobin less than 9.0 g/dL
- Thrombocytopenia with platelet count less than 100 x 10^12/L
- Positive for hepatitis B or hepatitis C virus or abnormal liver function exceeding twice the normal values for 2 weeks
- Chronic active infections such as Epstein-Barr virus, cytomegalovirus, or tuberculosis
- Secondary nephrotic syndrome such as purpuric nephritis or lupus nephritis
- Serious diseases of blood, endocrine system, heart, liver, or kidney
- Other autoimmune diseases, primary immunodeficiencies, or tumors
- Participation in other clinical trials within 3 months prior to enrollment
- Any condition judged by investigator to be unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jianhua Mao, MD
CONTACT
C
Chunyue Feng
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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