Prospective Observation of Bortezomib in the Treatment of Glomerular Diseases
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete Remission Rate of Proteinuria
研究概览
简要总结
Bortezomib is a proteasome inhibitor that inhibits autoantibody production, and reduces podocyte damage and mesangial hyperplasia caused by NF-κB activation in the kidney. Literature has reported that bortezomib can achieve a complete response rate of up to 38% in the treatment of glomerular diseases, but its safety and effectiveness remain to be assessed for the Chinese demographic. This study attempts to explore a new treatment plan for glomerular disease by observing the therapeutic effect of bortezomib on glomerular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glomerular diseases confirmed by renal biopsy (including IgA nephropathy, membranous nephropathy, FSGS, etc.)
- •Aged 18-65, male or female
- •Signed informed consent
- •24h proteinuria >1.5g/24h
- •Glomerular filtration rate (eGFR) >30ml/min/1.73m2 (calculated according to CKD-EPI formula) within 14 days before enrollment.
- •Blood pressure <140/90mmHg after drug treatment
- •Unless there are contraindications, subjects must take a steady dose of ACEI and/or ARB for at least 4 weeks before screening
排除标准
- •Renal pathology: glomerulosclerosis ratio >70%, interstitial fibrosis > severe
- •Received immunosuppressant treatment within the past 6 months
- •Inability to tolerate bortezomib
- •Platelet count < 30×109/L within 14 days before enrollment
- •Neutrophil count < 1.0×109/L within 14 days before enrollment
- •Subjects had >grade 2 peripheral neuropathy within 14 days before enrollment
- •ECG evidence of myocardial infarction or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmia, or acute ischemia or active conduction system abnormalities within 6 months before enrollment
- •Abnormal liver function such as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >=3 times normal upper limit (ULN), total bilirubin >= 2 times ULN
- •Newly diagnosed malignant tumor (within 5 years) or undergoing radiotherapy/chemotherapy
- •Women who are pregnant or breast-feeding, or women of childbearing age who cannot guarantee effective contraception
- •New serious life-threatening infections
- •Active infectious diseases such as active tuberculosis, active viral hepatitis, HIV infection.
- •Mental disorders and psychotropic drug uses
- •Patients with an estimated life expectancy of fewer than 12 months
- •Patients that were difficult to follow up on or had poor compliance
- •Patients who do not wish to sign the form of informed consent
研究组 & 干预措施
Glomerular disease patients
干预措施: Bortezomib (Drug)
结局指标
主要结局
Complete Remission Rate of Proteinuria
时间窗: One Year
24h Proteinuria \<300mg/24h
次要结局
- Safety of Bortezomib(One Year)
研究者
Nan Chen,MD
Principal Investigator,Director,Foreign academicians of the French National Academy of Medical Sciences,Director of institute of Nephrology affiliated to Shanghai Jiao Tong University Medical College
Ruijin Hospital