Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis

January 15, 2026 updated by: Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Age 3-17 years;
  2. Patients diagnosed with IgA vasculitis nephritis (IgAVN) based on clinical manifestations and renal pathological diagnosis;
  3. Urinary protein quantification requirements: urinary protein/creatinine ratio (UPCR) of ≥1 mg/mg (100 mg/mmol);
  4. Estimated glomerular filtration rate (eGFR) calculated using the modified Schwartz formula of ≥60 mL/min/1.73 m².
  5. Renal biopsy is optional (if a renal biopsy is performed, cases classified as International Society of Nephropathology (ISKDC) grade ≥IV must be excluded).

Exclusion Criteria:

  1. 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;
  2. 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);
  3. Patients with a history of tumors or severe cardiovascular, digestive system, hematological, endocrine, or other systemic diseases;
  4. Patients with concurrent other urinary system diseases (such as hereditary kidney diseases, etc.);
  5. Subjects with severe osteoporosis requiring treatment;
  6. Subjects diagnosed with uncontrolled mental illness or intellectual disabilities;
  7. Subjects who have received B-cell targeted therapy within the last 6 months;
  8. History of major organ transplant or hematopoietic stem cell/cell/bone marrow or kidney transplant;
  9. Vaccination with live attenuated vaccines within 1 month prior to treatment;
  10. 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);
  11. Incomplete clinical data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Glucocorticoids group
Throughout the treatment period, the participants were administered glucocorticoids but did not receive any immunosuppressants or biologic therapies.
Device: Collect clinical data from the patients.
This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions.
Drug: 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 interventions
Telitacicept group
Throughout the treatment period, the participants were administered telitacicept but did not receive any immunosuppressants, glucocorticoids and other biologic therapies.
Device: Collect clinical data from the patients.
This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions.
Drug: 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 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.
Device: Collect clinical data from the patients.
This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions.
Drug: 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 interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the 48th week after treatment
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.
From enrollment to the 48th week after treatment
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.
From enrollment to the 48th week after treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in renal function [Safety and Tolerability]
Time Frame: From enrollment to the 48th week after treatment.
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.
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.
The investigators will assess the changes in urinary red blood cell count (/μL) during long-term follow-up
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.
The investigators will assess the changes in serum immunoglobulin G、A and M levels (g/L) during long-term follow-up.
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.
The investigators will assess changes in total B and natural killer (TBNK) cells (/μL) during long-term follow-up
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.
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.
From enrollment to the 48th week after treatment.
Cumulative glucocorticoid dosage [Total Dosage]
Time Frame: From enrollment to the 48th week after treatment.
The investigators will calculate the cumulative glucocorticoid dosage (mg/kg) for each group during the follow-up period.
From enrollment to the 48th week after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Investigators

  • Study Chair: Jianhua Mao, Children's Hospital, Zhejiang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTPIgAVN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on IgA Vasculitis

Clinical Trials on Collect clinical data from the patients.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe