- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04224428
Role of Fexofenadine in Diabetic Kidney Disease
April 30, 2022 updated by: Basma Mahrous El-Fatatry, Tanta University
Role of Fexofenadine in Reducing Albuminurea in Patients With Diabetic Kidney Disease
- 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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt
- Faculty of Pharmacy, Tanta University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control group
|
lactose oral tablet
|
ACTIVE_COMPARATOR: Fexofenadine group
|
fexofenadine tablets 60 mg once daily will be taken for six months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percent change in urinary albumin creatinine ratio (UACR)
Time Frame: After 6 months
|
After 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urinary cyclophilin A
Time Frame: After 6 months
|
After 6 months
|
Urinary monocyte chemoattractant protein-1 (MCP-1)
Time Frame: After 6 months
|
After 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2020
Primary Completion (ACTUAL)
February 1, 2022
Study Completion (ACTUAL)
February 1, 2022
Study Registration Dates
First Submitted
January 8, 2020
First Submitted That Met QC Criteria
January 8, 2020
First Posted (ACTUAL)
January 13, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 5, 2022
Last Update Submitted That Met QC Criteria
April 30, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Kidney Diseases
- Diabetic Nephropathies
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Fexofenadine
Other Study ID Numbers
- FEXT20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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