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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Nephropathies

Intervention / Treatment
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* Drug: Valsartan 80 mg
* Drug: Empagliflozin 10 MG
* Drug: Levocetirizine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months | Drug: Valsartan 80 mg<br>* Valsartan is an angiotensin receptor blocker.<br>Drug: Empagliflozin 10 MG<br>* Empagliflozin is an oral hypoglycemic drug.<br>|
| Active Comparator: Levocetirizine group<br>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. | Drug: Valsartan 80 mg<br>* Valsartan is an angiotensin receptor blocker.<br>Drug: Empagliflozin 10 MG<br>* Empagliflozin is an oral hypoglycemic drug.<br>Drug: Levocetirizine<br>* Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of albuminuria | Reduction of albuminuria in diabetic nephropathy | 3 months |