A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
- Conditions
- IgA Nephropathy
- Interventions
- Registration Number
- NCT04905212
- Lead Sponsor
- RemeGen Co., Ltd.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
- IgA nephropathy confirmed by pathological biopsy;
- Male or female aged ≥ 18 years old;
- Average 24-hour urine total protein ≥ 0.75 g/24 h
- Estimated GFR (using the CKD-EPI formula) > 30 mL/min per 1.73 m^2;
- Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.
- Patients with clinically significant abnormal laboratory tests at screening;
- Evidence of rapid eGFR decrease > 15 ml/min during screening;
- Renal or other organ transplantation prior to, or expected during, the study;
- Patients with secondary IgA nephropathy;
- Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;
- Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
- Immunocompromised individuals.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telitacicept 160mg Telitacicept 160mg Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses Telitacicept 240mg Telitacicept 240mg Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses Placebo Placebo Placebo subcutaneous injection once weekly, and a total of 24 doses
- Primary Outcome Measures
Name Time Method Change from baseline in 24-hour urine protein at Week 24. Week 24 Change from baseline in urine protein over 24 hours to Week 24 will be measured
- Secondary Outcome Measures
Name Time Method Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48 Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48 Change from baseline in eGFR by visit
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; 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.
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. 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)
Trial Locations
- Locations (8)
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 #17
🇺🇸Augusta, Georgia, United States
Remegen Site #16
🇺🇸Fort Lauderdale, Florida, United States
Remegen Site #2
🇺🇸Philadelphia, Pennsylvania, United States
Remegen Site #10
🇺🇸Sacramento, California, United States
Remegen Site #8
🇺🇸San Francisco, California, United States