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Efficacy and Safety of Taltzcept Combined with Traditional Immunosuppressants in the Treatment of Immunoglobulin A Vasculitis Nephritis in Children: A Single-Center, Prospective Single-Arm, Historical Controlled Study

Efficacy and Safety of Taltzcept Combined with Traditional Immunosuppressants in the Treatment of Immunoglobulin A Vasculitis Nephritis in Children: A Single-Center, Prospective Single-Arm, Historical Controlled Study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128049
Enrollment
Unknown
Registered
2026-07-13
Start date
2025-09-11
Completion date
Unknown
Last updated
2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA vasculitis nephritis

Interventions

Prospective Treatment Group:Taltzcept

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 5 - 18 years, no gender restriction; 2. Clinical history of allergic purpura with 24-hour urine protein quantification >0.5 g/1.73m^2/day; 3. Renal biopsy confirming pediatric IgAVN; 4. Disease onset <6 months; 5. Patient and family voluntarily participate in this study and sign informed consent;

Exclusion criteria

Exclusion criteria: 1. Exclusion criteria for the prospective treatment group: (1) Allergic to or unable to tolerate Taitaxip; (2) Patients with underlying diseases such as severe infections, immunodeficiency, or hematologic diseases; (3) Exclude patients with other concurrent kidney diseases (such as hereditary kidney diseases); (4) eGFR <60 ml/min/1.73m^2 at onset; (5) Use of other biologics within the past 6 months; (6) Poor compliance and inability to cooperate to complete the study. 2. Exclusion criteria for the historical control group: (1) Patients with underlying conditions such as severe infections, immunodeficiency, or hematological diseases; (2) Patients with other coexisting kidney diseases (such as hereditary kidney diseases); (3) eGFR < 60 ml/min/1.73m^2 at onset; (4) Use of other biologics within the past 6 months; (5) Poor compliance and inability to cooperate to complete the study; (6) Lack of important baseline data or data at 24 weeks of treatment.

Design outcomes

Primary

MeasureTime frame
Remission rate of urinary protein at 24 weeks;

Secondary

MeasureTime frame
Recurrence rate of proteinuria within 24 weeks;Adverse event;Change in eGFR at 24 weeks of treatment;Remission rate of hematuria at 24 weeks of treatment;Cumulative dose of glucocorticoids;

Countries

China

Contacts

Public ContactKe Xu

Peking University First Hospital

18810530744@126.com+86 10 56957276

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026