Evaluating Levocetirizine for Diabetic Kidney Disease
Clinical Study to Evaluate the Possible Efficacy and Safety of Levocetirizine in Patients With Diabetic Kidney Disease
This study is testing if Levocetirizine can help improve kidney function and health in people aged 40 to 65 who have diabetes and kidney problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Mansoura) |
| Trial ID | NCT05638880 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the efficacy and safety of Levocetirizine in patients suffering from diabetic nephropathy, a common complication of diabetes that can lead to end-stage renal disease. The study will involve patients aged 40 to 65 with confirmed type II diabetes and persistent albuminuria, who are already receiving specific therapies. Participants will be monitored for changes in kidney function and overall health outcomes as they receive Levocetirizine alongside other medications.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 to 65 with type II diabetes and diagnosed diabetic nephropathy.
Not a fit: Patients with other types of diabetes or those with uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for managing diabetic kidney disease, potentially improving patient outcomes.
How similar studies have performed: While the specific use of Levocetirizine in this context is novel, other studies have explored various treatments for diabetic nephropathy with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mansoura
- Mansoura University — Mansoura, Egypt (Recruiting)
Study contacts
- Study coordinator: Maryam Ali, MSC
- Email: amaryam10324@gmail.com
- Phone: 0201060508406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.