A Phase 2 interventional study of Telitacicept 160mg and Telitacicept 240mg in IgA Nephropathy, sponsored by RemeGen Co., Ltd.. Terminated at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by RemeGen Co., Ltd. · Phase 2, Interventional, and Treatment
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).
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 15 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →RemeGen Co., Ltd. is the lead sponsor of 77 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Drug: Telitacicept 160mg
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Drug: Telitacicept 240mg
Placebo subcutaneous injection once weekly, and a total of 24 doses
Drug: Placebo
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.
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.
The incidence and severity of adverse events
Number and intensity of adverse events
Time frame: 27 weeks
Immunogenicity endpoints
Anti-drug antibody (ADA), incidence, titers and duration
Time frame: Week 0, 4, 8, 12, 16, 20, 24 and 27
Biomaker endpoints serum concentration
BLyS serum concentration, APRIL serum concentration, and BLyS-drug complex
Time frame: Week 0, 4, 8, 12, 16, 20, and 24
Pharmacokinetic endpoints
Free Telitacicept serum concentration and total Telitacicept serum concentration
Time frame: Week 0, 4, 8, 12, 16, 20, 24 and 27
Plan to share: No
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This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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RemeGen Co., Ltd.