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

Sponsor
The Affiliated Hospital of Xuzhou Medical University
Study ID
NCT07098897
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • IgA Nephropathy (IgAN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept 160mg — DRUG
    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.
  • Corticosteroid — DRUG
    Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants
  • ACE Inhibitor or Angiotensin receptor antagonist — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Jul 2025
Primary completion
May 25, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
150 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Target Therapy Group(TTG)
    Standard Supportive Care plus Telitacicept injected Subcutaneously 160mg/time, once a week for a total of 24 weeks Target based Drug: Telitacicept 160mg once a week for 24 weeks Other Name: RC18 Drug: Standard Supportive Care plus Low dosage of Corticosteroid(≤0.5mg/kg/d) without immunosuppressants Other Name: Prednisolone / Methylprednisolone
  • Active Comparator: Corticosteroid Therapy Group (CTG)
    Standard Supportive Care plus Corticosteroid Drug: Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants Other Name: Prednisolone / Methylprednisolone
  • Active Comparator: Supportive Care Group (SCG)
    Standard Supportive Care 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

Primary Outcome Measure

Complete remission of proteinuria [ Time Frame: Baseline/3months/6months ]

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