NCT07098897

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

To Evaluate the Effect and Safety of Telitacicept and Standard Treatment for 6months in IgA Nephropathy, Single Center, Randomized, Open Label, Comparative Study

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Telitacicept in patients with IgA nephropathy. The control group will be observed for up to 6months without administration of Telitacicept. This Single center, Randomized, Open Label, Comparative study will evaluate the effect and safety of and Standard treatment for 6months in IgA Nephropathy.

Detailed description

IgA nephropathy is the most common primary glomerulonephritis worldwide. Immune complexes, composed of galactose-deficient IgA1 and Gd-IgA1 autoantibodies, are deposited in the mesangial area of the glomeruli where they induce complement-mediated inflammation. This may result in the reduced kidney function, which can progress to end-stage kidney disease. Treatment options are very limited. It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR\>50ml/min/1.73m2 in IgA nephropathy, the KDIGO guidelines suggest a 6-month course of glucocorticoids. Many studies further showed that 6-month course of glucocorticoids with higher side effects and leading to discontinue of glucocorticoids course before the beneficial effect of 6months course. 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. This study is a Single center, Randomized, Open Label, Comparative study. In the study, around 60-100 patients with IgA nephropathy will be enrolled, and they will be treated with Telitacicept for 6 months on the basis of conventional treatment.

Conditions

• IgA Nephropathy (IgAN)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-05-25
• Completion: 2025-09-30
• First posted: 2025-08-01
• Last updated: 2025-08-01

Locations

1 site across 1 country: China