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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 65
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Egypt
Mansoura University
RECRUITING
Al Mansurah
Contact Information
Primary
Maryam Ali, MSC
amaryam10324@gmail.com
0201060508406
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2026-10-20
Participants
Target number of participants: 60
Treatments
Experimental: Control Group
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months
Active_comparator: Levocetirizine group
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.
Sponsors
Leads: Mostafa Bahaa
Collaborators: Tanta University

This content was sourced from clinicaltrials.gov