Randomized Control Trial to study the safety and efficacy of dual blockade of Renin Angiotensin Aldosterone System (RAAS) in Primary Glomerular diseases.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the incidence and severity of adverse event related to RAAS inhibition in patients with primary glomerular diseases
研究概览
简要总结
Glomerular diseases are one of the most important causes of chronic kidney disease in worldwide. They are leading cause of end stage renal disease in developing countries. Primary glomerular diseases mainly include Minimal change disease (MCD), Focal segmental glomerulosclerosis (FSGS), IgA Nephropathy (IgAN), idiopathic membranoproliferative glomerulonephritis (MPGN) and Membranous nephropathy (MN). Inhibition of Renin angiotensin aldosterone system (RAAS) is cornerstone of management of proteinuria in addition to immunosuppression. Number of trials and metanalysis have demonstrated that combination of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) have greater antiproteinuric effect than either agents alone.Publications of trials involving patients with diabetes demonstrated adverse effects of combined RAAS blockade. Uncertainty regarding the adverse effects with use of dual RAAS blockage prevents its use in primary glomerular diseases. Further trials are needed to study the combination therapy as evidence based practice. We wish to evaluate safety and efficacy of dual RAAS blockage in patients with primary glomerular diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with primary glomerular diseases – MN, FSGS, IgAn, iMPGN, MCD
- •Patients with who have received single RAAS blocking agent (LOSARTAN 100 mg) for atleast 4 weeks and having proteinuria more than 500 mg/day
- •Age >12 years
- •Either sex.
排除标准
- •Secondary glomerulonephritis.
- •Prior history of angioedema
- •Bilateral renal artery stenosis
- •Pregnancy
- •Serum Potassium more than 5.1 mmol/L
- •eGFR < 30 ml/min.
结局指标
主要结局
To evaluate the incidence and severity of adverse event related to RAAS inhibition in patients with primary glomerular diseases
时间窗: 1 year
次要结局
- 1. To study the decrease in proteinuria at the end of 1styear post randomization(2. To study the reduction in decline in eGFR at the end of 1styear post randomization)