Diabetic NephropathiesPhase 2NCT05638880
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
A Phase 2 study testing Valsartan 80 mg, Empagliflozin 10 MG and Levocetirizine in people with Diabetic Nephropathies, run by Mostafa Bahaa at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- Valsartan 80 mg, Empagliflozin 10 MG and Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2022to 20 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diabetic Nephropathies
- Being tested
- Valsartan 80 mg, Empagliflozin 10 MG, Levocetirizine
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 80 mgDrug
Valsartan is an angiotensin receptor blocker.
Empagliflozin 10 MGDrug
Empagliflozin is an oral hypoglycemic drug.
LevocetirizineDrug
Levocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | 30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months Receives: Drug: Valsartan 80 mg; Drug: Empagliflozin 10 MG |
| Levocetirizine group | Active comparator | 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. Receives: Drug: Valsartan 80 mg; Drug: Empagliflozin 10 MG; Drug: Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of albuminuria
Reduction of albuminuria in diabetic nephropathy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start20 Dec 2022
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mostafa Bahaa
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Mostafa Bahaa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638880
- Sponsor's protocol ID
- MS.21.21.1776
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rizk MA, El-Haggar SM, Ibrahim OM, Ghazi HA. Efficacy of levocetirizine in reducing albuminuria and inflammatory biomarkers in patients with diabetic kidney disease: A randomized controlled trial. J Diabetes Complications. 2025 Nov;39(11):109175. doi: 10.1016/j.jdiacomp.2025.109175. Epub 2025 Sep 10.
PubMed 40946347
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT05638880
- Acronym / sponsor ID
- MS.21.21.1776
- Conditions
- Diabetic Nephropathies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mostafa BahaaUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Drug: Valsartan 80 mg, Drug: Empagliflozin 10 MG30 patients will receive Valsartan 80 mg once daily titrated till blood pressure ≤ 130/80 plus Empagliflozin 10 mg once daily for 3 months |
| Levocetirizine group | Active comparator | Drug: Valsartan 80 mg, Drug: Empagliflozin 10 MG, Drug: Levocetirizine30 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Other types of diabetes mellitus
- Uncontrolled hypertension (Blood pressure ≥ 180/110).
- Urinary tract infection.
- Severe anemia (Hemoglobin ˂10).
- Critically ill patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valsartan 80 mgValsartan is an angiotensin receptor blocker. | Drug | Control Group, Levocetirizine group |
| Empagliflozin 10 MGEmpagliflozin is an oral hypoglycemic drug. | Drug | Control Group, Levocetirizine group |
| LevocetirizineLevocetirizine, Histamine-1 receptor antagonists provide a highly successful approach for controlling allergic and inflammatory conditions | Drug | Levocetirizine group |
Primary outcome
Reduction of albuminuria
Time frame: 3 months
Reduction of albuminuria in diabetic nephropathy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 40946347Rizk MA, El-Haggar SM, Ibrahim OM, Ghazi HA. Efficacy of levocetirizine in reducing albuminuria and inflammatory biomarkers in patients with diabetic kidney disease: A randomized controlled trial. J Diabetes Complications. 2025 Nov;39(11):109175. doi: 10.1016/j.jdiacomp.2025.109175. Epub 2025 Sep 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valsartan 80 mg, Empagliflozin 10 MG and Levocetirizine in people with Diabetic Nephropathies, run by Mostafa Bahaa at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of albuminuria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05638880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.