Study of Telitacicept in Patients With Refractory IgA Nephropathy

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT05596708
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — DRUG
    Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.

Study Details

The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy. The main questions it aims to answer are: * To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy. * To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy. Participants will be subcutaneously injected with 240mg of Telitacicept once per week. Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.

Key Dates

Start date
Mar 1, 2023
Status verified
Oct 2022
Primary completion
Jun 30, 2025
Completion
Sep 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept treated group

Primary Outcome Measure

Complete clinical response [ Time Frame: 3-year ]

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