Telitacicept in the Treatment of Pediatric IgA Vasculitis-Associated Nephritis

NCT07354503 | Not Yet Recruiting DMC FDA Drug FDA Device

• 1 other identifier: TTPIgAVN
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

IgAVN; IgA Vasculitis

Keywords

IgAV nephritis; Telitacicept; Children

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment to the 48th week after treatment.

Secondary Outcomes (6)

• Changes in renal function [Safety and Tolerability]

  From enrollment to the 48th week after treatment.

• Changes in urinary red blood cell count (/μL) [Efficacy]

  From enrollment to the 48th week after treatment.

• Changes in serum immunoglobulin levels [Safety and Tolerability]

  From enrollment to the 48th week after treatment.

• Changes in peripheral blood lymphocyte subsets[Efficacy]

  From enrollment to the 48th week after treatment.

• Incidence and severity of all adverse events[Safety and Tolerability]

  From enrollment to the 48th week after treatment.

Study Arms (3)

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.; 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.

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.

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

Interventions

Collect clinical data from the patients. DEVICE

This study exclusively prospectively collected clinical data from the patients and did not involve any therapeutic interventions.

Glucocorticoids combined Telitacicept group; Glucocorticoids group; Telitacicept group

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

Glucocorticoids combined Telitacicept group; Glucocorticoids group; Telitacicept group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Related Publications (9)

• 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.

  PMID: 40214779 RESULT

• Wang 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.

  PMID: 40042623 RESULT

• Liu 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.

  PMID: 40225367 RESULT

• Dhillon S. Telitacicept: First Approval. Drugs. 2021 Sep;81(14):1671-1675. doi: 10.1007/s40265-021-01591-1.

  PMID: 34463932 RESULT

• Zhang 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.

  PMID: 31377786 RESULT

• Ronkainen 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.

  PMID: 12241872 RESULT

• Jauhola 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.

  PMID: 20852275 RESULT

• Chang 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.

  PMID: 15947991 RESULT

• Watts 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.

  PMID: 34853411 RESULT

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

During the research process, it is necessary to collect peripheral blood and urine samples from the participants.

MeSH Terms

Conditions

IgA Vasculitis

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Jianhua Mao

  Children's Hospital, Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Aiqin Sheng

CONTACT

+8615715734421; shengaiqin99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 48 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Nephrology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share