Role of Fexofenadine in Diabetic Kidney Disease

Tanta University

Status and phase: Completed; Phase 3

Conditions: Diabetic Kidney Disease

Treatments: Drug: Fexofenadine Pill; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04224428

FEXT20

Details and patient eligibility

About

• 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Treatment:

Drug: Placebo oral tablet

Fexofenadine group

Active Comparator group

Treatment:

Drug: Fexofenadine Pill