A Study of Telitacicept for IgA Nephropathy (TELIGAN)

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05799287
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Primary IgA Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — BIOLOGICAL
    Subcutaneous injection
  • Placebo — DRUG
    Placebo to Telitacicept

Study Details

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Key Dates

Start date
Apr 28, 2023
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
318 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept
    Subjects will be given Telitacicept 240 mg SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.
  • Placebo Comparator: Placebo
    Subjects will be given placebo SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.

Primary Outcome Measure

Change from baseline in urine protein creatinine ratio (UPCR) [ Time Frame: 39 weeks ]

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