To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

May 25, 2025

Study Completion Date

September 30, 2025

Conditions
IgA Nephropathy (IgAN)
Interventions
DRUG

Telitacicept 160mg

Currently monoclonal antibodies, that may affect the main axis of pathogenesis of IgA nephropathy and biological therapy such as Telitacicept, provides a new treatment option and altering or depletion or modulation of Gd-IgA1 producing B cells and plasma cells. At present, Telitacicept are used for clinical treatment in IgA nephropathy patient inside China, but still clear data on safety and effect, and patient's complete remission, repeated relapse data are unclear.

DRUG

Corticosteroid

Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants

DRUG

ACE Inhibitor or Angiotensin receptor antagonist

Drug: ACE Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization Drug: ARB Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization

Trial Locations (1)

221000

The First Affiliated hospital of Xuzhou Medical University, Xuzhou

All Listed Sponsors
lead

The Affiliated Hospital of Xuzhou Medical University

OTHER