Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease

• Status: Recruiting
• Trial end date: 2026-10-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mostafa Bahaa
• Collaborators: Maryam Ali Ali El Sayed Rizk Clinical pharmacy Department- Tanta University; Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University; Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University
• Treatments: Empagliflozin; Levocetirizine; Valsartan

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.