A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Change from baseline in 24-hour urine protein at Week 24.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Telitacicept 160mg
Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
干预措施: Telitacicept 160mg (Drug)
Telitacicept 240mg
Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
干预措施: Telitacicept 240mg (Drug)
Placebo
Placebo subcutaneous injection once weekly, and a total of 24 doses
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in 24-hour urine protein at Week 24.
时间窗: Week 24
Change from baseline in urine protein over 24 hours to Week 24 will be measured
次要结局
- 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.)