A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
Overview
- Phase
- Phase 2
- Intervention
- Telitacicept 160mg
- Conditions
- IgA Nephropathy
- Sponsor
- RemeGen Co., Ltd.
- Enrollment
- 15
- Locations
- 8
- Primary Endpoint
- Change from baseline in 24-hour urine protein at Week 24.
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Telitacicept 160mg
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Intervention: Telitacicept 160mg
Telitacicept 240mg
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Intervention: Telitacicept 240mg
Placebo
Placebo subcutaneous injection once weekly, and a total of 24 doses
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in 24-hour urine protein at Week 24.
Time Frame: Week 24
Change from baseline in urine protein over 24 hours to Week 24 will be measured
Secondary Outcomes
- 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 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 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.)