Role of Fexofenadine in Diabetic Kidney Disease

Phase 3

Completed

• Conditions: Diabetic Kidney Disease
• Interventions: Drug: Fexofenadine Pill; Drug: Placebo oral tablet

• Registration Number: NCT04224428
• Lead Sponsor: Tanta University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-13
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-30
• Last Update Posted: 2022-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fexofenadine group	Fexofenadine Pill	-
Control group	Placebo oral tablet	-

Primary Outcome Measures

Name	Time	Method
Percent change in urinary albumin creatinine ratio (UACR)	After 6 months

Secondary Outcome Measures

Name	Time	Method
Urinary monocyte chemoattractant protein-1 (MCP-1)	After 6 months
Urinary cyclophilin A	After 6 months

Trial Locations

Locations (1)

Faculty of Pharmacy, Tanta University; 🇪🇬 Tanta, Egypt