Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2020-01-01
2022-02-01
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
Placebo oral tablet
lactose oral tablet
Fexofenadine group
Fexofenadine Pill
fexofenadine tablets 60 mg once daily will be taken for six months
Interventions
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Fexofenadine Pill
fexofenadine tablets 60 mg once daily will be taken for six months
Placebo oral tablet
lactose oral tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Basma Mahrous El-Fatatry
Principal investigator, Assistant lecturer of Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University
Locations
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Faculty of Pharmacy, Tanta University
Tanta, , Egypt
Countries
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References
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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.
Other Identifiers
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FEXT20
Identifier Type: -
Identifier Source: org_study_id
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