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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis
- ClinicalTrials.gov ID
- NCT07052981
- Acronym / sponsor ID
- 202504040-2
- Conditions
- IgA Nephropathy (IgAN), IgAVN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Guixia DingUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: TelitaciceptThe intervention measure for the experimental group is the administration of Telitacicept in addition to standard treatment |
| control group | No intervention | –The intervention measure for the control group is standard treatment (corticosteroids with or without other immunosuppressants) for 24 weeks. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelitaciceptThe study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks. | Drug | Experimental group |
Primary outcome
24-hour urinary protein
Time frame: At each follow-up visit(0、4、8、12、16、20、24week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telitacicept in people with IgA Nephropathy (IgAN) and IgAVN, run by Guixia Ding.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour urinary protein (time frame: At each follow-up visit(0、4、8、12、16、20、24week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.