Role of Fexofenadine in Diabetic Kidney Disease

NCT04224428 | Completed Phase 3

• 1 other identifier: FEXT20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Percent change in urinary albumin creatinine ratio (UACR)

  After 6 months

Secondary Outcomes (2)

• Urinary cyclophilin A

  After 6 months

• Urinary monocyte chemoattractant protein-1 (MCP-1)

  After 6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

Drug: Placebo oral tablet

Fexofenadine group

ACTIVE COMPARATOR

Drug: Fexofenadine Pill

Interventions

Fexofenadine Pill DRUG

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

Fexofenadine group

Placebo oral tablet DRUG

lactose oral tablet

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy, Tanta University

Tanta, Egypt

Location

Related Publications (1)

• El-Fatatry BM, El-Haggar SM, Ibrahim OM, Shalaby KH. Repurposing fexofenadine as a promising candidate for diabetic kidney disease: randomized clinical trial. Int Urol Nephrol. 2024 Apr;56(4):1395-1402. doi: 10.1007/s11255-023-03804-w. Epub 2023 Sep 23.

  PMID: 37741921 DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Assistant lecturer of Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: January 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)