IgA Nephropathy (IgAN)Phase 3NCT07052981
Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis
A Phase 3 study testing Telitacicept in people with IgA Nephropathy (IgAN) and IgAVN, run by Guixia Ding.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy (IgAN), IgAVN
- What is being tested?
- Telitacicept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
- Conditions
- IgA Nephropathy (IgAN), IgAVN
- Being tested
- Telitacicept
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelitaciceptDrug
The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The intervention measure for the experimental group is the administration of Telitacicept in addition to standard treatment Receives: Drug: Telitacicept |
| control group | No intervention | The intervention measure for the control group is standard treatment (corticosteroids with or without other immunosuppressants) for 24 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour urinary protein
Measured: At each follow-up visit(0、4、8、12、16、20、24week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guixia Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guixia Ding, Nanjing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052981
- Sponsor's protocol ID
- 202504040-2
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No