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Completed

NCT Number: NCT05638880

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

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.

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Key information

Conditions

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

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University

Al Mansurah, 315511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Reduction of albuminuria

    Time frame: 3 months

    Reduction of albuminuria in diabetic nephropathy

Sponsors and collaborators

Lead sponsor

Mostafa Bahaa

Other

Collaborators

  • Tanta University

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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