Diabetic Kidney DiseasePhase 3NCT04224428
Role of Fexofenadine in Diabetic Kidney Disease
A Phase 3 study testing Fexofenadine Pill in people with Diabetic Kidney Disease, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Fexofenadine Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Feb 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
- 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
- Being tested
- Fexofenadine Pill, Placebo oral tablet
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fexofenadine PillDrug
fexofenadine tablets 60 mg once daily will be taken for six months
Placebo oral tabletDrug
lactose oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Drug: Placebo oral tablet |
| Fexofenadine group | Active comparator | Not described Receives: Drug: Fexofenadine Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in urinary albumin creatinine ratio (UACR)
Measured: After 6 months
Secondary outcomes (2)
Urinary cyclophilin A
Measured: After 6 months
Urinary monocyte chemoattractant protein-1 (MCP-1)
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Mahrous El-Fatatry, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224428
- Sponsor's protocol ID
- FEXT20
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37741921
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fexofenadine in Reducing Albuminurea in Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT04224428
- Acronym / sponsor ID
- FEXT20
- Conditions
- Diabetic Kidney Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Placebo oral tablet |
| Fexofenadine group | Active comparator | Drug: Fexofenadine Pill |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus
- Severe renal impairment (eGFR< 30 mL/min/1.73 m2 at screening)
- Pregnant or lactating women
- Chronic heart failure
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fexofenadine Pillfexofenadine tablets 60 mg once daily will be taken for six months | Drug | Fexofenadine group |
| Placebo oral tabletlactose oral tablet | Drug | Control group |
Primary outcome
Percent change in urinary albumin creatinine ratio (UACR)
Time frame: After 6 months
2 secondary outcomes
Urinary cyclophilin A
Time frame: After 6 months
Urinary monocyte chemoattractant protein-1 (MCP-1)
Time frame: After 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 37741921El-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.
- Individual participant dataSharing planned: No
Related trials for Diabetic Kidney Disease
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fexofenadine Pill in people with Diabetic Kidney Disease, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in urinary albumin creatinine ratio (UACR) (time frame: After 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.