Role of Fexofenadine in Diabetic Kidney Disease

Diabetic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224428
• Other study ID #: FEXT20
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: April 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Kidney Disease
• Diabetic Nephropathies
• Kidney Diseases

Intervention

Drug:
• Fexofenadine Pill
fexofenadine tablets 60 mg once daily will be taken for six months
• Placebo oral tablet
lactose oral tablet

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Tanta University	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in urinary albumin creatinine ratio (UACR)		After 6 months
Secondary	Urinary cyclophilin A		After 6 months
Secondary	Urinary monocyte chemoattractant protein-1 (MCP-1)		After 6 months