This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy. The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Remegen Site #5
Los Angeles, California, United States
Remegen Site #13
Los Angeles, California, United States
Remegen Site #14
Los Angeles, California, United States
Remegen Site #10
Sacramento, California, United States
Change from baseline in 24-hour urine protein at Week 24.
Change from baseline in urine protein over 24 hours to Week 24 will be measured
Time frame: Week 24
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in eGFR by visit
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
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Remegen Site #8
San Francisco, California, United States
Remegen Site #16
Fort Lauderdale, Florida, United States
Remegen Site #17
Augusta, Georgia, United States
Remegen Site #2
Philadelphia, Pennsylvania, United States