NCT04291781已完成2 期
Phase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of IgA Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change from baseline in 24-hour urine protein excretion at Week 24;
研究概览
简要总结
To evaluate the safety and efficacy of Tai Ai (Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.
详细描述
Both RC18 and Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection are other names of Tai Ai.
After a 35-day screen period, subjects are randomly allocated into 3 groups receiving subcutaneous injection of Tai Ai 160mg, Tai Ai 240mg, and placebo once a week individually. The treatment lasts 24 weeks. Subjects, the sponsor, investigators are blinded in the whole process of the trial.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing the informed consent;
- •Biopsy confirmed diagnosis of IgA nephropathy;
- •Male or female, between 18 and 70 years age;
- •Before randomization, 24-hour urine protein excretion of ≥1g/24h in every screening visit;
- •Estimated glomerular filtration rate (eGFR) (CKD-EPI formula) of >45 ml/min per 1.73m2;
- •Have received the ACEI(Angiotension converting enzyme inhibitors)/ARB(Angiotensin receptor blocker) standard treatment for 24 weeks prior to randomization, and have stabled the dosage (within the maximum tolerated dosage) for 4 weeks prior to randomization.
排除标准
- •Significant abnormalities in clinical laboratory values (including, but not limited to, the following indicators)：
- •Items Abnormal value WBC(white blood cell count) <3*10^9/L PMN(Neutrophil count) <1.5*10^9/L HGB(hemoglobin) <85g/L PLT(blood platelet count) <80*10^9/L TBil(total bilirubin) >1.5*ULN ALT(Alanine aminotransferase) >3*ULN AST( Aspartate transaminase) >3*ULN ALP(alkaline phosphatase) >2*ULN CK(creatine kinase) >5*ULN
- •Any secondary IgA nephropathy caused by Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, sjogren syndrome, viral hepatitis, liver cirrhosis, rheumatoid arthritis, mixed connective tissue disease, polyarteritis nodosa, erythema nodosum, psoriasis, ulcerative colitis, crohn's disease, tumor, AIDS ,etc.;
- •Any nephropathy with special pathologic or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis(with >50% of biopsied glomeruli), IgA nephropathy with minimal change disease (MCD-IgAN); and IgA nephropathy requiring corticosteroids treatment.
- •Suffering from cardiovascular and cerebrovascular events (myocardial infarction, unstable angina, ventricular arrhythmia, New York heart association grade III-IV heart failure, stroke, etc.) within the last 12 weeks;
- •Treating with systemic corticosteroids drug(excluding topical or nasal steroids) within 6 months prior to randomizing;
- •Treating with systemic immunosuppressor within 6 months prior to randomizing: cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, tripterygium wilfordii, etc.;
- •Requiring hospitalization or intravenous antibiotics treatment due to active infection within 6 months prior to randomizing;
- •Active tuberculosis or latent carrier;
- •Positive in herpes zoster, HIV antibody or HCV antibody;
- •Active hepatitis or severe liver disease, and HBV infection (According to the HBV screening test, ①excluded the HBsAg-positive; ②HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.)
- •With malignant tumors;
- •Pregnancy or lactation, or patients with family planning during the experiment;
- •Inevitably administrate nephrotoxic drugs during the study period;
- •Allergy to human biological products;
- •Receiving any other experimental drug 4 weeks or 5 times half-life of the experimental drug (up to the longer time) prior to randomizing;
- •Not suitable for the study judged by investigator.
研究组 & 干预措施
RC18 160mg
Experimental
RC18 160mg subcutaneous injection (S.C.) once weekly ,and a total of 24 doses
干预措施: RC18 160mg (Biological)
RC18 240mg
Experimental
RC18 240mg S.C. once weekly ,and a total of 24 doses
干预措施: RC18 240mg (Biological)
Placebo
Placebo Comparator
Placebo S.C. once weekly ,and a total of 24 doses
干预措施: placebo (Biological)
结局指标
主要结局
Change from baseline in 24-hour urine protein excretion at Week 24;
时间窗: week 24
based on the 24 -hour urine collection
次要结局
- Change from baseline in estimated Glomerular Filtration Rate(eGFR)(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in urine protein/creatine ratio(UPCR) and/or urine albumin/ creatine ratio(UACR)(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in Immunoglobulin G(IgG);(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in Immunoglobulin M(IgM);(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in Immunoglobulin A(IgA);(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in the count of urine red blood cells(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in the count of B-lymphocytes (CD19+)(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in complement 3（C3）(week 0, 4, 8, 12, 16, 20, 24)
- Change from baseline in complement 4 (C4)(week 0, 4, 8, 12, 16, 20, 24)
- The incidence rate and severity of adverse events.(week 0, 4, 8, 12, 16, 20, 24)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II TrialMultiple Sclerosis, Relapsing-RemittingNCT04625153RemeGen Co., Ltd.8
已完成
2 期
A Study of TACI（Transmembrane Activator and Calcium-modulator and Cyclophilin Ligand (CAML) Interactor）-Antibody Fusion Protein Injection (RC18) in Subjects With Systemic Myasthenia GravisSystemic Myasthenia GravisNCT04302103RemeGen Co., Ltd.29
已完成
2 期
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeNCT04078386RemeGen Co., Ltd.42
终止
3 期
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica Spectrum DisordersNCT03330418RemeGen Co., Ltd.178
已完成
3 期
A Study of the Efficacy and Safety of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Inadequate Response to MTX Due to Treat Moderate and Severe Rheumatoid Arthritis.Moderate and Severe RheumatoId ArthritisNCT03016013RemeGen Co., Ltd.480