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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2026-10-20

Brief Summary

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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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Detailed Description

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Conditions

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Diabetic Nephropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Valsartan 80 mg

Intervention Type DRUG

Valsartan is an angiotensin receptor blocker.

Empagliflozin 10 MG

Intervention Type DRUG

Empagliflozin is an oral hypoglycemic drug.

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.

Group Type ACTIVE_COMPARATOR

Valsartan 80 mg

Intervention Type DRUG

Valsartan is an angiotensin receptor blocker.

Empagliflozin 10 MG

Intervention Type DRUG

Empagliflozin is an oral hypoglycemic drug.

Levocetirizine

Intervention Type DRUG

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

Interventions

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Valsartan 80 mg

Valsartan is an angiotensin receptor blocker.

Intervention Type DRUG

Empagliflozin 10 MG

Empagliflozin is an oral hypoglycemic drug.

Intervention Type DRUG

Levocetirizine

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No