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

Sponsor
Mostafa Bahaa
Study ID
NCT05638880
Phase
PHASE2
Status
Completed

Conditions

  • Diabetic Nephropathies

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Valsartan 80 mg — DRUG
    Valsartan is an angiotensin receptor blocker.
  • Empagliflozin 10 MG — DRUG
    Empagliflozin is an oral hypoglycemic drug.
  • Levocetirizine — DRUG
    Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions

Study Details

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.

Key Dates

Start date
Dec 20, 2022
Status verified
Mar 2026
Primary completion
Dec 20, 2025
Completion
Dec 20, 2025

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: 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.

Primary Outcome Measure

Reduction of albuminuria [ Time Frame: 3 months ]

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