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Role of Fexofenadine in Diabetic Kidney Disease

Primary Purpose

Diabetic Kidney Disease

Status

Completed

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Fexofenadine Pill

Placebo oral tablet

About this trial

This is an interventional treatment trial for Diabetic Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Faculty of Pharmacy, Tanta University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Fexofenadine group

Arm Description

Outcomes

Primary Outcome Measures

Percent change in urinary albumin creatinine ratio (UACR)

Secondary Outcome Measures

Urinary cyclophilin A

Urinary monocyte chemoattractant protein-1 (MCP-1)

Full Information

NCT ID

NCT04224428

First Posted

January 8, 2020

Last Updated

April 30, 2022

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT04224428

Brief Title

Role of Fexofenadine in Diabetic Kidney Disease

Official Title

Role of Fexofenadine in Reducing Albuminurea in Patients With Diabetic Kidney Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

February 1, 2022 (Actual)

Study Completion Date

February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Title

Fexofenadine group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Fexofenadine Pill

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo oral tablet

Intervention Description

lactose oral tablet

Primary Outcome Measure Information:

Title

Percent change in urinary albumin creatinine ratio (UACR)

Time Frame

After 6 months

Secondary Outcome Measure Information:

Title

Urinary cyclophilin A

Time Frame

After 6 months

Title

Urinary monocyte chemoattractant protein-1 (MCP-1)

Time Frame

After 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Faculty of Pharmacy, Tanta University

City

Tanta

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

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Role of Fexofenadine in Diabetic Kidney Disease

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