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Completed

NCT Number: NCT04224428

Role of Fexofenadine in Diabetic Kidney Disease

* This study will that will be conducted on 60 outpatients previously diagnosed with type 2 diabetes mellitus. * Patients will be recruited from Internal Medicine Department, Tanta University Hospital, Tanta, Egypt.

This study will be randomized, controlled, parallel, prospective clinical study. Accepted patients will be randomized into 2 groups as the following

* Group 1 (Control group): 30 patients will receive maximum tolerated dose of ACEI for six months * Group 2 (Fexofenadine group): 30 patients will receive maximum tolerated dose of ACEI plus fexofenadine tablets 60 mg once daily for six months

The primary end point will be the change in Urinary albumin to creatinine ratio (UACR) after six months of treatment

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Key information

Conditions

Diabetic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Pharmacy, Tanta University

Tanta, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females aged ≥ 18 years
  • Confirmed diagnosis of Type 2 diabetes mellitus at least 6 months prior to screening
  • Stage 2 and 3 diabetic nephropathy (persistent micro- or macroalbuminuria with urinary albumin creatinine ratio (UACR) >30mg/g) despite treatment with maximum tolerated dose of ACE inhibitors for at least 8 weeks prior to the screening
  • Hemoglobin A1c > 6.5 % with regular use of insulin and/or oral glucose lowering agents

Exclusion criteria

  • Type 1 diabetes mellitus
  • Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)
  • Pregnant or lactating women
  • Chronic heart failure
  • Malignancy
  • Inflammatory or autoimmune disease
  • History of kidney disease other than diabetic nephropathy

Treatment and study plan

Fexofenadine Pill

Drug

fexofenadine tablets 60 mg once daily will be taken for six months

Placebo oral tablet

Drug

lactose oral tablet

Primary outcomes

  1. Percent change in urinary albumin creatinine ratio (UACR)

    Time frame: After 6 months

Secondary outcomes

  1. Urinary cyclophilin A

    Time frame: After 6 months

  2. Urinary monocyte chemoattractant protein-1 (MCP-1)

    Time frame: After 6 months

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Role of Fexofenadine in Reducing Albuminurea in Patients With Diabetic Kidney Disease

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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