A Dose-Finding Pilot Study of ACTH on the Serum Lipoprotein Profile and Proteinuria in Patients With Idiopathic Membranous Nephropathy (MN)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in side effects/toxicity
研究概览
简要总结
This pilot study is aimed at demonstrating the effectiveness of ACTH (H.P. Acthar Gel) on the lipid profile and proteinuria in participants with MN. ACTH or adrenocorticotrophin is a hormone produced by the pituitary gland (a gland at the base of your brain) that is involved in stimulating your adrenal glands to secrete a number of steroid products (e.g. cortisol, aldosterone, corticosterone, and others) that are important in keeping you alive. The drug used in this study has been approved by the Food and Drug Administration (FDA) for routine clinical use in the treatment of patients with proteinuria and patients with idiopathic nephrotic syndrome such as idiopathic MN. However, the most adequate dose to use has not been adequately assessed. This is the reason for conducting this research study.
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
- None
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
- •Idiopathic MN with diagnostic biopsy performed less than 36 months from the time of dose randomization.
- •Age > 18 years.
- •Patients need to be treated with an ACEI and/or ARB, for at least 3 months prior to ACTH treatment and have adequately controlled blood pressure
- •Proteinuria of >4.0 on a 24-hour urine collection.
- •Estimated GFR >40 ml/min/1.73m2 while taking ACEI/ARB therapy.
排除标准
- •Age <18 years.
- •Estimated GFR <40 ml/min/1.73m2, or serum creatinine >2.0 mg/dl.
- •Renal biopsy showing more than 30% glomerulosclerosis and/or tubular atrophy.
- •Patient must be off glucocorticoid, calcineurin inhibitors (cyclosporin A, tacrolimus) or mycophenolic mofetil for >1 month, and alkylating agents or rituximab for >6 months.
- •Resistance to the following immunosuppressive routines e.g. steroids alone, calcineurin inhibitors plus or minus steroids, cytotoxic agents plus or minus steroids.
- •Patients with active infections or secondary causes of MN.
- •Type 1 or 2 diabetes mellitus.
- •Pregnancy or nursing.
- •Acute renal vein thrombosis documented prior to entry by renal US or CT scan and requiring anticoagulation therapy.
研究组 & 干预措施
Arm 1 ACTH 40 units
Receive ACTH at the dose of 40 units sub-cutaneously for up to 12 weeks. If at day 91 no response has been shown, you will have the option to increase the dose of ACTH to 80 units for up to an additional 120 days.
干预措施: ACTH (Drug)
Arm 2 ACTH 80 units
Receive ACTH at the dose of 80 units sub-cutaneously for up to 12 weeks.
干预措施: ACTH (Drug)
结局指标
主要结局
Change in side effects/toxicity
时间窗: baseline, 3 months
Change in proteinuria
时间窗: baseline, 3 months
Change in LDL cholesterol, HDL cholesterol, and triglycerides
时间窗: baseline, 3 months
次要结局
- Number of subjects with CR or PR(3 months)
- The effect of maximizing angiotensin II blockade on proteinuria(3 months)