Evaluating Telitacicept for Children with Nephrotic Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Telitacicept plus baricitinib for refractory rheumatoid arthritis

  This test tries combining telitacicept with baricitinib to see if it helps adults with refractory rheumatoid arthritis who haven't improved on other treatments.

  Recruiting Zhejiang Provincial People's Hospital · Hangzhou, Zhejiang · NCT07491016

• Dupilumab for nephrotic syndrome in children

  This study will try dupilumab to help children with steroid‑dependent or frequently relapsing nephrotic syndrome stay in remission and relapse less often.

  Recruiting at 2 sites Phase 2 National University Hospital, Singapore · Singapore, Singapore and 1 other locations · NCT07091175

• SG301 (anti-CD38) injection for children with frequently relapsing or steroid-dependent nephrotic syndrome

  This Phase 2 trial will test whether SG301 (an anti-CD38 antibody) injections are safe and help children aged 6–18 who have frequently relapsing or steroid‑dependent nephrotic syndrome.

  Recruiting Phase 2 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07087314

• Combining telitacicept and tofacitinib for treating difficult rheumatoid arthritis

  This study tests if combining two medications, telitacicept and tofacitinib, can help adults with tough-to-treat rheumatoid arthritis feel better when other treatments haven't worked.

  Recruiting Zhejiang Provincial People's Hospital · Hangzhou, Zhejiang · NCT06979271

• Evaluating telitacicept for treating IgA nephropathy

  This study is testing if a new treatment called telitacicept can help people with IgA nephropathy who are at high risk of their condition getting worse.

  Recruiting Ruijin Hospital · Shanghai · NCT06654596

• Using Adrenocorticotropic Hormone to Treat Children with Nephrotic Syndrome

  This study is testing if adding a hormone treatment to steroids can help children with nephrotic syndrome feel better and have fewer side effects.

  Recruiting at 8 sites Phase 3 The Children's Hospital of Zhejiang University School of Medicine · Wuhan, Hubei and 7 other locations · NCT06079788

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.