Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of albuminuria
研究概览
简要总结
The prevalence of diabetes mellitus is increasing worldwide, and its complications are one of the leading causes of mortality from non-communicable diseases. Due to the high prevalence of diabetes and because 30-40% of diabetic patients [both type 1 (T1DM) and type 2 (T2DM) diabetes mellitus] develop kidney dysfunction, diabetic nephropathy (DN) is the main cause of end-stage renal disease worldwide. The renin-angiotensin-aldosterone system (RAAS), endothelin, and urotensin II are vasoactive hormones that have been extensively studied as other mediators although their relation to diabetic nephropathy is still speculative.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 and
- •Both genders will be included.
- •Type II diabetes mellitus confirmed by Glycosylated Hemoglobin A₁C.
- •Diagnosis of diabetic nephropathy, which will be defined as persistent albuminuria with urinary albumin creatinine ratio (UACR) range [30-300 mg /gm], confirmed on at least two occasions 3-6 months apart, with or without decline in glomerular filtration rate at screening and receiving angiotensin receptor blockers (ARBs) and sodium-glucose cotransporter 2 (SGLT2) inhibitors therapy.
- •Hemoglobin A₁C ranges from 6.5% to 10% with regular use of insulin and or/oral hypoglycemic drugs.
排除标准
- •Other types of diabetes mellitus
- •Uncontrolled hypertension (Blood pressure ≥ 180/110).
- •Urinary tract infection.
- •Severe anemia (Hemoglobin ˂10).
- •Critically ill patient.
- •Past operation, past history of trauma, heavy exercise.
- •Severe renal failure (e GFR ˂ 30ml/min/1.73 m2).
- •Systemic inflammatory and autoimmune diseases.
- •Malignancy.
- •Pregnancy and lactating women.
- •Other causes of chronic kidney disease.
研究组 & 干预措施
Control Group
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months
干预措施: Valsartan 80 mg (Drug)
Control Group
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months
干预措施: Empagliflozin 10 MG (Drug)
Levocetirizine group
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily plus Levocetirizine 5 mg once daily in the evening titrated according to creatinine clearance for 3 months.
干预措施: Valsartan 80 mg (Drug)
Levocetirizine group
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily plus Levocetirizine 5 mg once daily in the evening titrated according to creatinine clearance for 3 months.
干预措施: Empagliflozin 10 MG (Drug)
Levocetirizine group
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily plus Levocetirizine 5 mg once daily in the evening titrated according to creatinine clearance for 3 months.
干预措施: Levocetirizine (Drug)
结局指标
主要结局
Reduction of albuminuria
时间窗: 3 months
Reduction of albuminuria in diabetic nephropathy
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University