IgAVNNCT07354503
Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis
An observational study of IgAVN and IgA Vasculitis, run by The Children's Hospital of Zhejiang University School of Medicine.
Trial summary
To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- IgAVN, IgA Vasculitis
- What is being tested?
- Collect clinical data from the patients. and This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Jun 2028
- How long will I take part?
- 48 Weeks
- Phase
- Observational
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Collect patients diagnosed with childhood IgA vasculitis nephritis who received treatment with glucocorticoids and/or telitacicept during the treatment period and met the inclusion and exclusion criteria.
Who may be able to join
- Age 3-17 years;
- Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;
- Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol);
- Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m².
- Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).
Who cannot join
- Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;
- Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000/μL); moderate to severe anemia (hemoglobin <9.0 g/dL); thrombocytopenia (platelet count <100×10^12/L); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);
- Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;
- Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);
- Subjects with severe osteoporosis requiring treatment;
- Subjects diagnosed with uncontrolled mental illness or intellectual disabilities;
Show all 11Show fewer
- Subjects who have received B-cell targeted therapy within the last 6 months;
- History of major organ transplant or hematopoietic stem cell/cell/bone marrow or kidney transplant;
- Vaccination with live attenuated vaccines within 1 month prior to treatment;
- Use of various traditional Chinese medicines for treating kidney diseases during the treatment period (patients who have previously used traditional Chinese medicine can be included, but are strictly prohibited from using it after receiving treatment according to the protocol);
- Incomplete clinical data.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis: A Multicenter Clinical Study
To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. It aims to compare the efficacy of Telitacicept with that of glucocorticoids, thereby providing clinicians with a reference for the rational and standardized application of Telitacicept.
Read the detailed description
IgA vasculitis (IgAV) is a common form of vasculitis in children, with an annual incidence ranging from 6.1 to 55.9 cases per 100,000 children. The highest incidence is observed in those aged 4 to 6 years. When the kidneys are affected, the condition is referred to as IgAV nephritis (IgAVN), impacting approximately 20% to 80% of children with IgAV, thus making it one of the most prevalent secondary glomerular diseases in this population. Most cases of childhood IgAVN are mild or self-limiting; however, a subset of children may experience severe renal involvement, which may manifest as nephrotic syndrome, significant proteinuria, elevated serum creatinine levels, hypertension, persistent proteinuria, and renal biopsy results indicating over 50% crescent involvement. Research indicates that among children with moderate to severe proteinuria due to IgAVN, approximately 10% to 20% may progress to end-stage renal disease (ESRD), with persistent proteinuria identified as an independent risk factor for poor prognosis in IgAVN. Currently, clinical management primarily relies on corticosteroids, calcineurin inhibitors (CNI), mycophenolate mofetil (MMF), cyclophosphamide (CTX), and other immunosuppressants. However, some children exhibit poor responses to conventional treatments, and prolonged use of these medications may lead to various adverse effects, including infections, metabolic disorders, and growth impairment.
The increased presence of galactose-deficient IgA1 (Gd-IgA1) in circulation is a critical factor in the pathogenesis of IgAVN. Gd-IgA1 serves as an antigen that binds to autoantibodies, resulting in the deposition of immune complexes in the mesangium of the glomeruli, mesangial proliferation, inflammation, and subsequent glomerular damage. Telitacicept is a transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) fused protein that specifically binds to both B lymphocyte stimulator (BLys) and a proliferation-inducing ligand (APRIL), thereby inhibiting the maturation and differentiation of B lymphocytes, plasma cell formation, and antibody production. A multicenter retrospective clinical study of Telitacicept in children with refractory IgA nephropathy (IgAN) and IgAVN demonstrated a gradual decrease in proteinuria in both groups throughout the treatment period, with consistent trends observed. In the IgAVN subgroup, following treatment with Telitacicept for 4, 12, 24, 36, and 48 weeks, 24-hour urinary protein levels decreased by 65.1%, 77.2%, 91.2%, 84.7%, and 85.8%, respectively, compared to baseline, while the urine protein-to-creatinine ratio (UPCR) decreased by 41.3%, 65.4%, 77.9%, 82.2%, and 87.8%. Additionally, a study involving seven children with IgAVN reported a 68.3% reduction in average 24-hour urinary protein after 24 weeks of Telitacicept treatment, with stable estimated glomerular filtration rates (eGFR) maintained throughout the treatment period. Furthermore, another study indicated that after 24 weeks of Telitacicept treatment, urinary protein levels significantly decreased, and hematuria improved markedly. None of the three studies reported serious adverse events.
Despite these promising findings, the clinical application of Telitacicept in children with IgAVN is still in the early exploratory stage, based on small sample studies with limited clinical follow-up. To further assess the efficacy and safety of Telitacicept in treating pediatric IgAVN in real-world settings, this study employs a multicenter retrospective plus prospective observational research design to compare the efficacy of Telitacicept withglucocorticoids, aiming to provide a reference for clinicians regarding the rational and standardized application of Telitacicept.
- Conditions
- IgAVN, IgA Vasculitis
- Being tested
- Collect clinical data from the patients., This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions
- Keywords
- IgAV nephritis, Telitacicept, Children
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect clinical data from the patients.Device
This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions.
This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventionsDrug
This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions
| Study group | Role | What they receive |
|---|---|---|
| Glucocorticoids group | Throughout the treatment period, the participants were administered glucocorticoids but did not receive any immunosuppressants or biologic therapies. Receives: Device: Collect clinical data from the patients.; Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions | |
| Telitacicept group | Throughout the treatment period, the participants were administered telitacicept but did not receive any immunosuppressants, glucocorticoids and other biologic therapies. Receives: Device: Collect clinical data from the patients.; Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions | |
| Glucocorticoids combined Telitacicept group | Throughout the treatment period, the participants were administered both glucocorticoids and telitacicept but did not receive any immunosuppressants or other biologic therapies. Receives: Device: Collect clinical data from the patients.; Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate of urinary protein [Efficacy]
Compared to the baseline, the investigators will assess the proportions of participants with a urine protein-to-creatinine ratio (UPCR) < 0.2 mg/mg (or 20 mg/mmol) or 24-hour urinary protein quantification< 0.2 g/d at weeks 12, 24, and 48 after medication administration.
Measured: From enrollment to the 48th week after treatment
The rate of change in urinary protein [Efficacy]
The investigators will assess the UPCR(mg/mg or mg/mmol) of participants at 12, 24, and 48 weeks after medication administration, comparing the results against the baseline and conducting inter-group comparisons.
Measured: From enrollment to the 48th week after treatment
The rate of change in urinary protein [Efficacy]
The investigators will assess 24-hour urine protein quantification(g/d) of participants at 12, 24, and 48 weeks after medication administration, comparing the results against the baseline and conducting inter-group comparisons.
Measured: From enrollment to the 48th week after treatment.
Secondary outcomes (6)
Changes in renal function [Safety and Tolerability]
The investigators will assess the changes in estimated glomerular filtration rate (eGFR)(mL/min/1.73m^2) during long-term follow-up, with inter-group comparisons.
Measured: From enrollment to the 48th week after treatment.
Changes in urinary red blood cell count (/μL) [Efficacy]
The investigators will assess the changes in urinary red blood cell count (/μL) during long-term follow-up
Measured: From enrollment to the 48th week after treatment.
Changes in serum immunoglobulin levels [Safety and Tolerability]
The investigators will assess the changes in serum immunoglobulin G、A and M levels (g/L) during long-term follow-up.
Measured: From enrollment to the 48th week after treatment.
Changes in peripheral blood lymphocyte subsets[Efficacy]
The investigators will assess changes in total B and natural killer (TBNK) cells (/μL) during long-term follow-up
Measured: From enrollment to the 48th week after treatment.
Incidence and severity of all adverse events[Safety and Tolerability]
The investigators will assess incidence and severity of all adverse events, including the incidence of infections and hypogammaglobulinemia and the incidence of side effects associated with glucocorticoids.
Measured: From enrollment to the 48th week after treatment.
Cumulative glucocorticoid dosage [Total Dosage]
The investigators will calculate the cumulative glucocorticoid dosage (mg/kg) for each group during the follow-up period.
Measured: From enrollment to the 48th week after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for IgAVNStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 48 Weeks
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Jianhua Mao, Study chair, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354503
- Sponsor's protocol ID
- TTPIgAVN
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jin Y, Zhu J, Sheng A, Lin Q, Zhao M, He X, Mao J, Fu H. Telitacicept as a BAFF/APRIL dual inhibitor: efficacy and safety in reducing proteinuria for refractory childhood IgA vasculitis nephritis. Pediatr Nephrol. 2025 Aug;40(8):2561-2569. doi: 10.1007/s00467-025-06769-3. Epub 2025 Apr 11.
PubMed 40214779Wang J, Cui J, Chen J, Liao Y, Yang M, Lin J, Yang X, Zhao B. Telitacicept use in children with IgA vasculitis nephritis: preliminary observations. Pediatr Nephrol. 2025 Sep;40(9):2829-2836. doi: 10.1007/s00467-025-06709-1. Epub 2025 Mar 5.
PubMed 40042623Liu J, Han X, Jiang X, Gao X, Li G, Fang X, Chen J, Zhai Y, Liu J, Pei Y, Zhang J, Zhu G, Shen Q, Xu H. Efficacy and Safety of Telitacicept as an Add-On Therapy for Refractory Immunoglobulin A Nephropathy or Immunoglobulin A Vasculitis Nephropathy in Children. Kidney Int Rep. 2024 Dec 2;10(3):940-943. doi: 10.1016/j.ekir.2024.11.1363. eCollection 2025 Mar. No abstract available.
PubMed 40225367Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.
PubMed 34463932Zhang X, Xie X, Shi S, Liu L, Lv J, Zhang H. Plasma galactose-deficient immunoglobulin A1 and loss of kidney function in patients with immunoglobulin A vasculitis nephritis. Nephrol Dial Transplant. 2020 Dec 4;35(12):2117-2123. doi: 10.1093/ndt/gfz151.
PubMed 31377786Ronkainen J, Nuutinen M, Koskimies O. The adult kidney 24 years after childhood Henoch-Schonlein purpura: a retrospective cohort study. Lancet. 2002 Aug 31;360(9334):666-70. doi: 10.1016/S0140-6736(02)09835-5.
PubMed 12241872Jauhola O, Ronkainen J, Koskimies O, Ala-Houhala M, Arikoski P, Holtta T, Jahnukainen T, Rajantie J, Ormala T, Turtinen J, Nuutinen M. Renal manifestations of Henoch-Schonlein purpura in a 6-month prospective study of 223 children. Arch Dis Child. 2010 Nov;95(11):877-82. doi: 10.1136/adc.2009.182394. Epub 2010 Sep 18.
PubMed 20852275Chang WL, Yang YH, Wang LC, Lin YT, Chiang BL. Renal manifestations in Henoch-Schonlein purpura: a 10-year clinical study. Pediatr Nephrol. 2005 Sep;20(9):1269-72. doi: 10.1007/s00467-005-1903-z. Epub 2005 Jun 10.
PubMed 15947991Watts RA, Hatemi G, Burns JC, Mohammad AJ. Global epidemiology of vasculitis. Nat Rev Rheumatol. 2022 Jan;18(1):22-34. doi: 10.1038/s41584-021-00718-8. Epub 2021 Dec 1.
PubMed 34853411
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis: A Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07354503
- Acronym / sponsor ID
- TTPIgAVN
- Conditions
- IgAVN, IgA Vasculitis
- Keywords
- IgAV nephritis, Telitacicept, Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
To further evaluate the efficacy and safety of Telitacicept in the treatment of pediatric IgA vasculitis nephritis (IgAVN) within real-world settings, this study employs a multicenter, retrospective and prospective observational research design. It aims to compare the efficacy of Telitacicept with that of glucocorticoids, thereby providing clinicians with a reference for the rational and standardized application of Telitacicept.
Detailed description
IgA vasculitis (IgAV) is a common form of vasculitis in children, with an annual incidence ranging from 6.1 to 55.9 cases per 100,000 children. The highest incidence is observed in those aged 4 to 6 years. When the kidneys are affected, the condition is referred to as IgAV nephritis (IgAVN), impacting approximately 20% to 80% of children with IgAV, thus making it one of the most prevalent secondary glomerular diseases in this population. Most cases of childhood IgAVN are mild or self-limiting; however, a subset of children may experience severe renal involvement, which may manifest as nephrotic syndrome, significant proteinuria, elevated serum creatinine levels, hypertension, persistent proteinuria, and renal biopsy results indicating over 50% crescent involvement. Research indicates that among children with moderate to severe proteinuria due to IgAVN, approximately 10% to 20% may progress to end-stage renal disease (ESRD), with persistent proteinuria identified as an independent risk factor for poor prognosis in IgAVN. Currently, clinical management primarily relies on corticosteroids, calcineurin inhibitors (CNI), mycophenolate mofetil (MMF), cyclophosphamide (CTX), and other immunosuppressants. However, some children exhibit poor responses to conventional treatments, and prolonged use of these medications may lead to various adverse effects, including infections, metabolic disorders, and growth impairment.
The increased presence of galactose-deficient IgA1 (Gd-IgA1) in circulation is a critical factor in the pathogenesis of IgAVN. Gd-IgA1 serves as an antigen that binds to autoantibodies, resulting in the deposition of immune complexes in the mesangium of the glomeruli, mesangial proliferation, inflammation, and subsequent glomerular damage. Telitacicept is a transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) fused protein that specifically binds to both B lymphocyte stimulator (BLys) and a proliferation-inducing ligand (APRIL), thereby inhibiting the maturation and differentiation of B lymphocytes, plasma cell formation, and antibody production. A multicenter retrospective clinical study of Telitacicept in children with refractory IgA nephropathy (IgAN) and IgAVN demonstrated a gradual decrease in proteinuria in both groups throughout the treatment period, with consistent trends observed. In the IgAVN subgroup, following treatment with Telitacicept for 4, 12, 24, 36, and 48 weeks, 24-hour urinary protein levels decreased by 65.1%, 77.2%, 91.2%, 84.7%, and 85.8%, respectively, compared to baseline, while the urine protein-to-creatinine ratio (UPCR) decreased by 41.3%, 65.4%, 77.9%, 82.2%, and 87.8%. Additionally, a study involving seven children with IgAVN reported a 68.3% reduction in average 24-hour urinary protein after 24 weeks of Telitacicept treatment, with stable estimated glomerular filtration rates (eGFR) maintained throughout the treatment period. Furthermore, another study indicated that after 24 weeks of Telitacicept treatment, urinary protein levels significantly decreased, and hematuria improved markedly. None of the three studies reported serious adverse events.
Despite these promising findings, the clinical application of Telitacicept in children with IgAVN is still in the early exploratory stage, based on small sample studies with limited clinical follow-up. To further assess the efficacy and safety of Telitacicept in treating pediatric IgAVN in real-world settings, this study employs a multicenter retrospective plus prospective observational research design to compare the efficacy of Telitacicept withglucocorticoids, aiming to provide a reference for clinicians regarding the rational and standardized application of Telitacicept.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 48 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucocorticoids group | – | Device: Collect clinical data from the patients., Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventionsThroughout the treatment period, the participants were administered glucocorticoids but did not receive any immunosuppressants or biologic therapies. |
| Telitacicept group | – | Device: Collect clinical data from the patients., Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventionsThroughout the treatment period, the participants were administered telitacicept but did not receive any immunosuppressants, glucocorticoids and other biologic therapies. |
| Glucocorticoids combined Telitacicept group | – | Device: Collect clinical data from the patients., Drug: This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventionsThroughout the treatment period, the participants were administered both glucocorticoids and telitacicept but did not receive any immunosuppressants or other biologic therapies. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Collect patients diagnosed with childhood IgA vasculitis nephritis who received treatment with glucocorticoids and/or telitacicept during the treatment period and met the inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Age 3-17 years;
- Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;
- Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol);
- Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m².
- Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).
Key exclusion criteria (11 listed)
- Patients with congenital or acquired immunodeficiency, or those with concurrent tuberculosis, active cytomegalovirus (CMV), Epstein-Barr virus(EBV), hepatitis B, hepatitis C, Human Immunodeficiency Virus(HIV) infection, deep fungal infections, or other active infections;
- Patients exhibiting the following abnormal laboratory indicators at the time of initial diagnosis: moderate to severe neutropenia (≤1000/μL); moderate to severe anemia (hemoglobin <9.0 g/dL); thrombocytopenia (platelet count <100×10^12/L); or abnormal liver function (Alanine Aminotransferase(ALT), Aspartate Aminotransferase(AST), or bilirubin exceeding 2.5 times the upper limit of normal and persistently elevated for 2 weeks);
- Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;
- Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);
- Subjects with severe osteoporosis requiring treatment;
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 |
|---|---|---|
| Collect clinical data from the patients.This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions. | Device | Glucocorticoids combined Telitacicept group, Glucocorticoids group, Telitacicept group |
| This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventionsThis study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions | Drug | Glucocorticoids combined Telitacicept group, Glucocorticoids group, Telitacicept group |
Primary outcome
Complete remission rate of urinary protein [Efficacy]
Time frame: From enrollment to the 48th week after treatment
Compared to the baseline, the investigators will assess the proportions of participants with a urine protein-to-creatinine ratio (UPCR) < 0.2 mg/mg (or 20 mg/mmol) or 24-hour urinary protein quantification< 0.2 g/d at weeks 12, 24, and 48 after medication administration.
The rate of change in urinary protein [Efficacy]
Time frame: From enrollment to the 48th week after treatment
The investigators will assess the UPCR(mg/mg or mg/mmol) of participants at 12, 24, and 48 weeks after medication administration, comparing the results against the baseline and conducting inter-group comparisons.
The rate of change in urinary protein [Efficacy]
Time frame: From enrollment to the 48th week after treatment.
The investigators will assess 24-hour urine protein quantification(g/d) of participants at 12, 24, and 48 weeks after medication administration, comparing the results against the baseline and conducting inter-group comparisons.
6 secondary outcomes
Changes in renal function [Safety and Tolerability]
Time frame: From enrollment to the 48th week after treatment.
Changes in urinary red blood cell count (/μL) [Efficacy]
Time frame: From enrollment to the 48th week after treatment.
Changes in serum immunoglobulin levels [Safety and Tolerability]
Time frame: From enrollment to the 48th week after treatment.
Changes in peripheral blood lymphocyte subsets[Efficacy]
Time frame: From enrollment to the 48th week after treatment.
Incidence and severity of all adverse events[Safety and Tolerability]
Time frame: From enrollment to the 48th week after treatment.
Cumulative glucocorticoid dosage [Total Dosage]
Time frame: From enrollment to the 48th week after treatment.
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 21 Jan 2026.
- Results publication: PubMed 40214779Jin Y, Zhu J, Sheng A, Lin Q, Zhao M, He X, Mao J, Fu H. Telitacicept as a BAFF/APRIL dual inhibitor: efficacy and safety in reducing proteinuria for refractory childhood IgA vasculitis nephritis. Pediatr Nephrol. 2025 Aug;40(8):2561-2569. doi: 10.1007/s00467-025-06769-3. Epub 2025 Apr 11.
- Results publication: PubMed 40042623Wang J, Cui J, Chen J, Liao Y, Yang M, Lin J, Yang X, Zhao B. Telitacicept use in children with IgA vasculitis nephritis: preliminary observations. Pediatr Nephrol. 2025 Sep;40(9):2829-2836. doi: 10.1007/s00467-025-06709-1. Epub 2025 Mar 5.
- Results publication: PubMed 40225367Liu J, Han X, Jiang X, Gao X, Li G, Fang X, Chen J, Zhai Y, Liu J, Pei Y, Zhang J, Zhu G, Shen Q, Xu H. Efficacy and Safety of Telitacicept as an Add-On Therapy for Refractory Immunoglobulin A Nephropathy or Immunoglobulin A Vasculitis Nephropathy in Children. Kidney Int Rep. 2024 Dec 2;10(3):940-943. doi: 10.1016/j.ekir.2024.11.1363. eCollection 2025 Mar. No abstract available.
- Results publication: PubMed 34463932Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.
- Results publication: PubMed 31377786Zhang X, Xie X, Shi S, Liu L, Lv J, Zhang H. Plasma galactose-deficient immunoglobulin A1 and loss of kidney function in patients with immunoglobulin A vasculitis nephritis. Nephrol Dial Transplant. 2020 Dec 4;35(12):2117-2123. doi: 10.1093/ndt/gfz151.
- Results publication: PubMed 12241872Ronkainen J, Nuutinen M, Koskimies O. The adult kidney 24 years after childhood Henoch-Schonlein purpura: a retrospective cohort study. Lancet. 2002 Aug 31;360(9334):666-70. doi: 10.1016/S0140-6736(02)09835-5.
- Results publication: PubMed 20852275Jauhola O, Ronkainen J, Koskimies O, Ala-Houhala M, Arikoski P, Holtta T, Jahnukainen T, Rajantie J, Ormala T, Turtinen J, Nuutinen M. Renal manifestations of Henoch-Schonlein purpura in a 6-month prospective study of 223 children. Arch Dis Child. 2010 Nov;95(11):877-82. doi: 10.1136/adc.2009.182394. Epub 2010 Sep 18.
- Results publication: PubMed 15947991Chang WL, Yang YH, Wang LC, Lin YT, Chiang BL. Renal manifestations in Henoch-Schonlein purpura: a 10-year clinical study. Pediatr Nephrol. 2005 Sep;20(9):1269-72. doi: 10.1007/s00467-005-1903-z. Epub 2005 Jun 10.
- Results publication: PubMed 34853411Watts RA, Hatemi G, Burns JC, Mohammad AJ. Global epidemiology of vasculitis. Nat Rev Rheumatol. 2022 Jan;18(1):22-34. doi: 10.1038/s41584-021-00718-8. Epub 2021 Dec 1.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis
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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.
Jianhua Mao study chair
The Children's Hospital of Zhejiang University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of IgAVN and IgA Vasculitis, run by The Children's Hospital of Zhejiang University School of Medicine.
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 5 inclusion and 11 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 21 Jan 2026. 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.
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?
Contact Aiqin Sheng (+8615715734421, shengaiqin99@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate of urinary protein [Efficacy] (time frame: From enrollment to the 48th week after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354503, which also lists 9 linked publications.
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 21 Jan 2026.