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

Primary Purpose

Diabetic Nephropathies

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Valsartan 80 mg
Empagliflozin 10 MG
Levocetirizine
Sponsored by
Mostafa Bahaa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Control Group

Levocetirizine group

Arm Description

30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months

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.

Outcomes

Primary Outcome Measures

Reduction of albuminuria
Reduction of albuminuria in diabetic nephropathy

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
February 7, 2023
Sponsor
Mostafa Bahaa
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05638880
Brief Title
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Official Title
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 20, 2025 (Anticipated)
Study Completion Date
October 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mostafa Bahaa
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Experimental
Arm Description
30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months
Arm Title
Levocetirizine group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Valsartan 80 mg
Intervention Description
Valsartan is an angiotensin receptor blocker.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
Empagliflozin is an oral hypoglycemic drug.
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Intervention Description
Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions
Primary Outcome Measure Information:
Title
Reduction of albuminuria
Description
Reduction of albuminuria in diabetic nephropathy
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maryam Ali, MSC
Phone
0201060508406
Email
amaryam10324@gmail.com
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
315511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam Ali, MSC
Phone
0201060508406
Email
amaryam10324@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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