NCT07052981Not yet recruitingPhase 3
Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis
Source: ClinicalTrials.gov · Last updated 10 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This clinical trial is a prospective, multicenter, non-randomized controlled study designed to evaluate the efficacy and safety of Telitacicept, a novel biologic agent, in treating pediatric IgA Nephropathy (IgAN) and IgA Vasculitis Nephritis (IgAVN). The study plans to enroll 124 children aged 5-18, divided into a test group (standard therapy + Telitacicept) and a control group (standard therapy alone), with a 24-week treatment period. The primary endpoint is the change in 24-hour urine protein levels at week 24, while secondary outcomes include UPCR (urine protein-to-creatinine ratio), eGFR, and drug safety.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 30 Jun 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Guixia Ding
- Diseases
- IgA nephropathy
- NCT number
- NCT07052981
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 124
- From 1 Aug 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- There is an ongoing infection that requires antiviral drugs or antibiotics for treatment.
- The patient has received other B cell-targeting biologics within the three months prior to enrollment.
- Patients with uncontrolled severe hypertension or diabetes. Individuals with other autoimmune diseases, primary immunodeficiencies, or tumors.
- A history of organ transplantation. Patients with chronic active infections, such as Epstein-Barr virus, cytomegalovirus, or Mycobacterium tuberculosis, whose disease state may be exacerbated by the use of steroids and immunosuppressive agents.
- Patients with severe liver failure, heart failure, or end-stage renal disease (ESRD).
- Any other medical conditions that may place the patient at increased risk by participating in this study.
- Individuals deemed by the investigator as unsuitable for participation in this study.
Who the study is looking for
- Diagnosed with IgA nephropathy (IgAN) or IgA vasculitis nephritis (IgAVN) Aged 5 to 18 years Weight ≥25 kg Moderate or heavy proteinuria At enrollment, estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m² calculated using the Schwartz formula (36.5 × height \[cm\] / serum creatinine \[μmol/L\]).
- Willing to sign the informed consent form
Age in the registry: 5 years to 18 years · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.