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

Diabetic Nephropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638880
• Other study ID #: MS.21.21.1776
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2022
• Est. completion date: October 20, 2026

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: Maryam Ali, MSC
• Phone: 0201060508406
• Email: amaryam10324[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 20, 2026
• Est. primary completion date: December 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Valsartan 80 mg
Valsartan is an angiotensin receptor blocker.
• Empagliflozin 10 MG
Empagliflozin is an oral hypoglycemic drug.
• Levocetirizine
Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura

Sponsors (4)

Lead Sponsor	Collaborator
Mostafa Bahaa	Maryam Ali Ali El Sayed Rizk Clinical pharmacy Department- Tanta University, Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University, Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of albuminuria	Reduction of albuminuria in diabetic nephropathy	3 months