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

NCT05638880 | Completed Phase 2

• 1 other identifier: MS.21.21.1776
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Nephropathies

Outcome Measures

Primary Outcomes (1)

• Reduction of albuminuria

  Reduction of albuminuria in diabetic nephropathy

  3 months

Study Arms (2)

Control Group

EXPERIMENTAL

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; Drug: Empagliflozin 10 MG

Levocetirizine group

ACTIVE COMPARATOR

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; Drug: Empagliflozin 10 MG; Drug: Levocetirizine

Interventions

Valsartan 80 mg DRUG

Valsartan is an angiotensin receptor blocker.

Control Group; Levocetirizine group

Empagliflozin 10 MG DRUG

Empagliflozin is an oral hypoglycemic drug.

Control Group; Levocetirizine group

Levocetirizine DRUG

Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions

Levocetirizine group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Bahaa: lead
• Tanta University: collaborator

Study Sites (1)

Mansoura University

Al Mansurah, 315511, Egypt

Location

Related Publications (1)

• Rizk MA, El-Haggar SM, Ibrahim OM, Ghazi HA. Efficacy of levocetirizine in reducing albuminuria and inflammatory biomarkers in patients with diabetic kidney disease: A randomized controlled trial. J Diabetes Complications. 2025 Nov;39(11):109175. doi: 10.1016/j.jdiacomp.2025.109175. Epub 2025 Sep 10.

  PMID: 40946347 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Valsartan; empagliflozin; levocetirizine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 6, 2022
• Study Start: December 20, 2022
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

EG (1)