NCT05638880CompletedPhase 2
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
Source: ClinicalTrials.gov · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 28 Nov 2022
- Start date
- 20 Dec 2022
- Primary completion date
- 20 Dec 2025
- Lead sponsor
- Mostafa Bahaa
- Diseases
- Chronic kidney disease
- NCT number
- NCT05638880
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 60
- From 20 Dec 2022 to the primary completion date, 20 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other types of diabetes mellitus
- Uncontrolled hypertension (Blood pressure ≥ 180/110).
- Urinary tract infection.
- Past operation, past history of trauma, heavy exercise.
- Systemic inflammatory and autoimmune diseases.
- Malignancy.
- Other causes of chronic kidney disease.
Lab values
- Severe anemia (Hemoglobin ˂10).
- Severe renal failure (e GFR ˂ 30ml/min/1.73 m2).
Other
- Critically ill patient.
- Pregnancy and lactating women.
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mansoura University Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.