Incidence and Relapse of Idiopathic Nephrotic Syndrome: Meta-analysis.
Floor Veltkamp, Leonie R Rensma, Antonia H M Bouts...
https://pubmed.ncbi.nlm.nih.gov/34193618Actively Recruiting
Phase 3
Age: 2Years - 18Years
All Genders
ID06125405
Study of Telitacicept in Children 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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying telitacicept in children aged 2 to 18 years with frequently relapsing or steroid-dependent nephrotic syndrome, a common kidney disease in children that can be hard to treat. This condition often requires long-term steroid use which can cause serious side effects. The study aims to find out if telitacicept can offer better results and safety compared to existing treatments, addressing a significant need for improved options in this condition. Participants will receive weekly subcutaneous injections of telitacicept for 52 weeks. The dose varies based on body weight, ranging from 40mg to 160mg per week. This is an open-label trial where all enrolled children will be treated with telitacicept to assess its effects over one year. During the study, children will be closely monitored through regular tests including urine protein levels, kidney function, blood tests, and body mass index measurements. Researchers will track relapse rates over 12 months and measure how long it takes for the first relapse to occur. Safety and changes in health markers like hemoglobin and albumin levels will also be evaluated to understand the impact of the treatment over the year-long study period.
CONDITIONS
Brief Title
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Who Can Participate
Age: 2Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children aged 2 to 18 years
- Diagnosed with frequently relapsing or steroid-dependent nephrotic syndrome
- Normal kidney function with estimated glomerular filtration rate of at least 90 ml/min/1.73m2
- Morning urine protein less than 1+ or urine protein-creatinine ratio less than 0.2 g/g for 3 consecutive days at enrollment
- No rituximab used within 6 months before enrollment
- No use of tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide within 3 months before enrollment
- No ACTH used within 3 months before enrollment
You will not qualify if you...
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia
- Low white blood cell count (leukopenia)
- Moderate to severe anemia with hemoglobin less than 9.0 g/dL
- Low platelet count (thrombocytopenia)
- Positive hepatitis B or C infection or abnormal liver function tests
- Chronic active infections such as Epstein-Barr virus, cytomegalovirus, or tuberculosis
- Secondary nephrotic syndrome caused by other diseases like lupus nephritis
- Serious blood, endocrine, heart, liver, or kidney diseases
- Other autoimmune diseases, immunodeficiencies, or tumors
- Participation in another clinical trial within 3 months prior to enrollment
- Judgment of unsuitability for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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 - 52 weeks
Participants receive weekly subcutaneous injections of Telitacicept to treat frequently relapsing or steroid-dependent nephrotic syndrome.
Weekly visits for 52 weeks
Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Loading map...
Research Team
J
Jianhua Mao, MD
C
Chunyue Feng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Nephrotic syndrome in childhood.
Allison A Eddy, Jordan M Symons
https://pubmed.ncbi.nlm.nih.gov/12944064Is there really an increase in non-minimal change nephrotic syndrome in children?
Guido Filler, Elizabeth Young, Pavel Geier...
https://pubmed.ncbi.nlm.nih.gov/14655180Prognostic significance of the early course of minimal change nephrotic syndrome: report of the International Study of Kidney Disease in Children.
P Tarshish, J N Tobin, J Bernstein...
https://pubmed.ncbi.nlm.nih.gov/9176846Telitacicept: First Approval.
Sohita Dhillon
https://pubmed.ncbi.nlm.nih.gov/34463932Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease.
Fan Shi, Ran Xue, Xuexiao Zhou...
https://pubmed.ncbi.nlm.nih.gov/34519594Telitacicept for autoimmune nephropathy.
Jingjing Cai, Dan Gao, Dongwei Liu...
https://pubmed.ncbi.nlm.nih.gov/37342346The efficacy and safety of telitacicept for the treatment of systemic lupus erythematosus: a real life observational study.
Ruilin Chen, Rong Fu, Zeying Lin...
https://pubmed.ncbi.nlm.nih.gov/36416639Randomized Phase 2 Trial of Telitacicept in Patients With IgA Nephropathy With Persistent Proteinuria.
Jicheng Lv, Lijun Liu, Chuanming Hao...
https://pubmed.ncbi.nlm.nih.gov/36938094Telitacicept for minimal change disease.
Shan Li, Lin Ding, Yan-Jiang Yang...
https://pubmed.ncbi.nlm.nih.gov/37440467