Changes in Autoreactive Memory B Cells as Biomarker of Response to Adrenocorticotropic Hormone in Patients With Membranous Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Proteinuria
研究概览
简要总结
The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. Acthar is a hormone that stimulates steroid production from small glands above the kidneys. It has direct protective effects on the kidney and is currently approved by the FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.
详细描述
Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years
- •Free of immunosuppression for at least 3 months
- •Capability of understanding the purpose of the study
- •Written informed consent
排除标准
- •Epidermal growth factor receptor (eGFR) < 30ml/min/1.73m2
- •Kidney Transplant
- •Secondary MN (defined on the basis of clinical criteria)
- •Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)
- •History of previous use of Acthar for treatment of nephrotic syndrome
- •Prior sensitivity to Acthar or other porcine protein products
- •Contraindication to Acthar per Prescribing Information
- •Planned treatment with live or live attenuated vaccines once enrolled in the study
- •More than three previous treatment regiments
- •Participation to other clinical trials over the previous 12 months
- •History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
- •Pregnancy
- •Lactation
- •Current substance abuse
- •Any clinically relevant condition that might affect study participation and/or study results
研究组 & 干预措施
Acthar
Acthar will be administered subcutaneously (SC) 80 units for the first week and then 80 units twice weekly
干预措施: ACTHar (Drug)
结局指标
主要结局
Change in Proteinuria
时间窗: baseline and 12 months
Change in proteinuria at baseline versus after 12 months of treatment as measured by urine protein/creatinine ratio
次要结局
- Number of Participants With Complete or Partial Remission(12 months)
- Anti-PLA2R Antibodies Levels(12 months)
- Estimated Glomerular Filtration Rate (GFR)(baseline and 12 months)
- Change in CD4+CD25+CD127low T Regulatory Cells/CD4+ T Cell Ratio(baseline and 12 months)
- Change in Serum Albumin(baseline 6 months, 12 months)
- Number of Anti-PLA2R Memory B Cells(12 months)
研究者
Paolo Cravedi
Assistant Professor, Nephrology
Icahn School of Medicine at Mount Sinai