Comparison of the Role of Losartan Alone vs Hydrochlorothiazide Plus Losartan on Proteinuria in Diabetic Nephropathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Reduction of proteinuria
研究概览
简要总结
Losartan, an angiotensin II receptor blocker, has already been established as a treatment for diabetic nephropathy due to its ability to reduce blood pressure and mitigate the progression of kidney damage. However, the addition of a diuretic like hydrochlorothiazide may offer synergistic benefits in reducing proteinuria by addressing both the underlying renal pathology and potential volume overload in these patients. The current study aims at determining and comparing the role of losartan alone vs hydrochlorothiazide plus losartan in reducing proteinuria in diabetic nephropathy patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both genders with ≥18 years of age.
- •Presence of proteinuria/albuminuria at time of screening.
- •Creatinine clearance of 30 mL/min or higher.
排除标准
- •A systolic blood pressure of 180 mm Hg or higher, a diastolic blood pressure of 110 mm Hg or higher.
- •Presence of a second primary renal disease in addition to diabetic nephropathy.
- •Patients with type 1 diabetes.
- •A history of a cardiovascular or cerebrovascular event within 3 months before inclusion.
- •Serum potassium of 6.0 mmol/L or higher.
- •Transplantation or immunosuppressive treatment.
- •Contraindication for the use of losartan or hydrochlorothiazide.
- •Pregnancy or lactation.
研究组 & 干预措施
Losartan group
Patients will receive Losartan (LS) 50 mg per day.
干预措施: Losartan (Drug)
Losartan + Hydrochlorothiazide
Patients will be given losartan LS (50 mg per day) and Hydrochlorothiazide (HCTZ) 12.5 mg per day as a combination therapy.
干预措施: Losartan + Hydrochlorothiazide (Drug)
结局指标
主要结局
Reduction of proteinuria
时间窗: 4 months
Efficacy will be labeled yes if reduction of proteinuria/albuminuria from the value before commencing treatment will be observed.
次要结局
未报告次要终点