Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Diabetic Nephropathies
About this trial
This is an interventional treatment trial for Diabetic Nephropathies
Eligibility Criteria
Inclusion Criteria: Age between 40 and 65. 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. Exclusion Criteria: 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.
Sites / Locations
- Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Control Group
Levocetirizine 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
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.