Clinical Study on the Efficacy and Safety of Telitacicept in the Treatment of Pediatric IgA Nephropathy or IgA Vasculitis Nephritis

NCT ID: NCT07052981

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2027-06-30

Brief 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). 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

The intervention measure for the experimental group is the administration of Telitacicept in addition to standard treatment

Group Type: EXPERIMENTAL

Telitacicept

Intervention Type: DRUG

The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.

control group

The intervention measure for the control group is standard treatment (corticosteroids with or without other immunosuppressants) for 24 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Telitacicept

The study duration was 24 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 24 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guixia Ding

OTHER

Sponsor Role: lead

Responsible Party

Guixia Ding

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

202504040-2

Identifier Type: -

Identifier Source: org_study_id