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

Sponsor

Mostafa Bahaa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05638880

Collaborator

Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University (Other), Osama Mohamed Hassan Ibrahim , Prof Clinical pharmacy Department- Tanta University (Other), Maryam Ali Ali El Sayed Rizk Clinical pharmacy Department- Tanta University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Drug: Valsartan 80 mg Drug: Empagliflozin 10 MG Drug: Levocetirizine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Dec 20, 2022

Anticipated Primary Completion Date :

Dec 20, 2025

Anticipated Study Completion Date :

Oct 20, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

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

Drug: Valsartan 80 mg

Valsartan is an angiotensin receptor blocker.

Drug: Empagliflozin 10 MG

Empagliflozin is an oral hypoglycemic drug.

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.

Drug: Valsartan 80 mg

Valsartan is an angiotensin receptor blocker.

Drug: Empagliflozin 10 MG

Empagliflozin is an oral hypoglycemic drug.

Drug: Levocetirizine

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

Outcome Measures

Primary Outcome Measures

Reduction of albuminuria [3 months]
Reduction of albuminuria in diabetic nephropathy

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University	Mansoura		Egypt	315511

Sponsors and Collaborators

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