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

Phase 2

Recruiting

• Conditions: Diabetic Nephropathies
• Interventions: Drug: Valsartan 80 mg; Drug: Empagliflozin 10 MG; Drug: Levocetirizine

• Registration Number: NCT05638880
• Lead Sponsor: Mostafa Bahaa

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-06
• Study Start: 2022-12-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-12-20
• Study Completion: 2026-10-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levocetirizine group	Empagliflozin 10 MG	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.
Control Group	Empagliflozin 10 MG	30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months
Levocetirizine group	Valsartan 80 mg	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.
Control Group	Valsartan 80 mg	30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months
Levocetirizine group	Levocetirizine	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 Measures

Name	Time	Method
Reduction of albuminuria	3 months	Reduction of albuminuria in diabetic nephropathy

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Egypt