Evaluating Telitacicept for Children with Nephrotic Syndrome
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
This study is testing if a new treatment called telitacicept can help children with nephrotic syndrome feel better and have fewer side effects than the usual medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine Academic / other |
| Drugs / interventions | rituximab, cyclophosphamide |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06125405 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of telitacicept in pediatric patients aged 2 to 18 years who suffer from frequently relapsing or steroid-dependent nephrotic syndrome. The study will follow participants for 52 weeks to determine if telitacicept offers better efficacy compared to conventional treatments while also evaluating its safety profile. Given the challenges associated with long-term steroid use and traditional immunosuppressants, this trial seeks to provide a new treatment option that minimizes side effects. The trial is conducted as a prospective, single-center, open-label study at The Children's Hospital of Zhejiang University School of Medicine.
Who should consider this trial
Good fit: Ideal candidates are children aged 2 to 18 years with frequently relapsing or steroid-dependent nephrotic syndrome and normal renal function.
Not a fit: Patients with a family history of nephrotic syndrome or those with certain blood disorders or viral infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the frequency of relapses and reliance on steroids in children with nephrotic syndrome.
How similar studies have performed: Previous studies have shown telitacicept to be effective in various kidney diseases, indicating potential success in this novel application for pediatric nephrotic syndrome.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sensitive but frequent relapses or steroids dependence nephrotic syndrome * Age: 2 to 18 years old * Normal renal function: estimated glomerular filtration rate ≥90ml/ min/1.73m2 * Morning urine protein \<1+ or urine protein-creatinine ratio \<0.2g/g (\<20 mg/ mmol) for 3 consecutive days and above when in enroll * No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment Exclusion Criteria: * Family history of nephrotic syndrome, chronic glomerulonephritis or uremia * Leukopenia (White Blood Cells ≤ 3.0 \* 10\^9 / L) * Moderate to severe anemia (hemoglobin \<9.0 g/dL) * Thrombocytopenia (platelet count \<100\*10\^12/L) * Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks) * There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness * Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.) * Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney * Those who with other autoimmune diseases or primary immunodeficiencies or tumors * Those who have participated in other clinical trials within three months prior to the enrollment * Those who was not suitable for participating this study judged by investigator
Where this trial is running
Hangzhou, Zhejiang
- Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jianhua Mao, MD — The Children's Hospital of Zhejiang University School of Medicine
- Study coordinator: Jianhua Mao, MD
- Email: maojh88@zju.edu.cn
- Phone: 86057186670015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.