NCT06125405 Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
| NCT ID | NCT06125405 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Condition | Nephrotic Syndrome in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-28 |
| Primary Completion | 2026-10-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 20 participants in total. It began in 2023-11-28 with a primary completion date of 2026-10-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Jianhua Mao, MD
PRINCIPAL INVESTIGATOR
The Children's Hospital of Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT06125405 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Nephrotic Syndrome in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06125405 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 20 participants.
Is NCT06125405 currently recruiting?
Yes, NCT06125405 is actively recruiting participants. Contact the research team at maojh88@zju.edu.cn for enrollment information.
Where is the NCT06125405 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06125405 clinical trial?
NCT06125405 is sponsored by The Children's Hospital of Zhejiang University School of Medicine. The principal investigator is Jianhua Mao, MD at The Children's Hospital of Zhejiang University School of Medicine. The trial plans to enroll 20 participants.