Efficacy and safety of daily oral steroid and cyclophosphamide versus cyclical steroid and cyclophosphamide in adult nephrotic syndrome patients with membranous nephropathy :A Randomized Controlled Trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To compare the remission rate (complete or partial) at 6 months in patients treated with daily oral steroid plus cyclophosphamide versus cyclical steroid and cyclophosphamide therapy
研究概览
简要总结
Membranous Nephropathy is the most common cause of nephrotic syndrome in adults. The oldest and most widely accepted treatment is alternate monthly steroid and cyclophosphamide, also known as the modified Ponticelli regimen. This regimen requires hospitalisation for three days for administration of intravenous steroid in the first, which is then followed by oral steroids for the remaining 27 days. This schedule is followed in the first, third, fifth month. In the second, fourth and sixth month patient is given oral cyclophosphamide. This regimen requires a fair degree of patient understanding and compliance, and also the need for hospitalisation.
There has been no study till date evaluating a completely oral regimen for treatment of membranous nephropathy. An oral regimen where cycplophosphamide and steroid is administered daily for three months, followed by only steroid for the remaining three months, will be easier for the patient to follow. It will not require hospitalisation and can ensure patient compliance. In this regimen, the total cumulative dose of steroid will be lower.
So our study attempts to evaluate both efficacy and safety of the oral regimen to the already established treatment of alternate cyclical steroid and cyclophosphamide in the treatment of adult nephrotic syndrome patients with membranous nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18 to 80 years with nephrotic syndrome 2.Membranous nephropathy diagnosed by renal biopsy 3.Patients classified as moderate risk, high risk or very risk as defined by KDIGO 2021 guidelines for membranous nephropathy 4.Estimated GFR more than 30 ml/min/1.73m2 of body surface area, as calculated using CKD-EPI formula 5.In females, has to be practicing medically approved method of contraception, or surgically sterile or post-menopausal.
排除标准
- •Secondary causes of membranous nephropathy will be excluded (SLE, medications like NSAIDs, COX-2 inhibitors, malignancy)
- •Active underlying infection, including but not limited to hepatitis B, hepatitis C, HIV
- •Pregnant or breast-feeding women
- •Allergy or hypersensitivity to cyclophosphamide (oral or intravenous)
- •Immunosuppressant intake in the 6 months prior to enrolment.
结局指标
主要结局
To compare the remission rate (complete or partial) at 6 months in patients treated with daily oral steroid plus cyclophosphamide versus cyclical steroid and cyclophosphamide therapy
时间窗: 6 months
次要结局
- 1.To compare proportion of patients with relapse in both treatment groups at 12 and 24 months.(2.To compare renal survival (patients not having more than 50% decline from baseline eGFR or not developing ESRD) and patient survival in both groups at 12 and 24 months.)
研究者
Dr Paromita Das
All India Institute of Medical sciences, Bhubaneswar