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

Launched by MOSTAFA BAHAA · Nov 28, 2022

Trial Information

Current as of January 14, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a medication called Levocetirizine in people who have diabetic kidney disease, a common complication of diabetes. Diabetic nephropathy occurs when diabetes causes damage to the kidneys, leading to issues with kidney function. The study aims to enroll adults aged 40 to 65 who have been diagnosed with type 2 diabetes and have specific signs of kidney problems, such as high levels of protein in their urine. Participants must also be receiving certain diabetes medications, like angiotensin receptor blockers (ARBs) and SGLT2 inhibitors.

If you or a family member are interested in participating, you should be aware that the trial is currently recruiting, and you may be eligible if you meet the age and health criteria. However, certain conditions, such as uncontrolled high blood pressure or severe kidney failure, would disqualify you. Participants can expect to be closely monitored throughout the study to assess any changes in their health and how well the medication works. Overall, this study is important as it aims to find better treatments for those suffering from diabetic kidney disease.

Gender

ALL

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.

About Mostafa Bahaa

Mostafa Bahaa is a dedicated clinical trial sponsor committed to advancing medical research and patient care through rigorous and ethical clinical studies. With a focus on innovative therapeutic solutions, the organization collaborates with leading researchers and healthcare institutions to ensure the highest standards of scientific integrity and regulatory compliance. Mostafa Bahaa prioritizes patient safety and data transparency, striving to contribute valuable insights that enhance treatment options and improve health outcomes across diverse medical fields.

Locations

Mansoura, , Egypt

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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