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

Mostafa Bahaa

Status and phase: Enrolling; Phase 2

Conditions: Diabetic Nephropathies

Treatments: Drug: Valsartan 80 mg; Drug: Levocetirizine; Drug: Empagliflozin 10 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05638880

MS.21.21.1776

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control Group

Experimental group

Description:

30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months

Treatment:

Drug: Empagliflozin 10 MG

Drug: Valsartan 80 mg

Levocetirizine group

Active Comparator group

Description:

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.

Treatment:

Drug: Empagliflozin 10 MG

Drug: Valsartan 80 mg

Drug: Levocetirizine