SGLT2i Kideny Protection Against Contrast in Diabetic KidneyNCT04853615
SGLT2 Inhibitors Prophylaxis Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease?
An observational study of SGLT2i Kideny Protection Against Contrast in Diabetic Kidney, run by Fayoum University.
Trial summary
We will look for the possible effect of SGLT2i as a single agent to prevent post-contrast Acute Kidney Injury in diabetic kidney disease. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- SGLT2i Kideny Protection Against Contrast in Diabetic Kidney
- What is being tested?
- Empagliflozin 25 MG
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Aug 2024
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration
Who may be able to join
- Age: more than30years, Diabetes, Diabetic kidney disease, GFR: more than30ml/min/1.73m2
Who cannot join
- Diabetics Patients with GFR less than 30 mL/min/1.73 m2.
Trial locations and contacts
No sites are listed yet.
Ahmed Fayed, MD contact
About this study
Official title: Is SGLT2 Inhibitors a Better Prophylactic Agent Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease? A Multicenter Prospective Randomized Controlled Study
We will look for the possible effect of SGLT2i as a single agent to prevent post-contrast Acute Kidney Injury in diabetic kidney disease.
Read the detailed description
Population of Study o Group 1 :
- st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast.
- Group 2 :
- nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily
- Group 3 :
- rd group will receive the SGLT2i empagliflosin 25 mg once daily
- Group 4 :
- thwill receive allopurinol and empagliflosin.
Inclusion Criteria :
- Age: more than30years, diabetes,diabetic kidney disease,GFR: more than30ml/min/1.73m2
Exclusion Criteria :
- Diabetics Patients with GFR less than 30 mL/min/1.73 m2.
Sample Size ( number of participants included ) :
800 patients Fayoum University Faculty of Medicine Scientific Research Ethics Committee
Methodology in details :
The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration. Baseline serum creatinine will be obtained 72 hours before the planned intervention and before administration of any protective protocol and follow-up serum creatinine will be obtained 72 hours and 1 week after contrast administration. The first control group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. Saline should be given by infusion pump to guarantee steady rate of infusion. 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily. 3rd group will receive the SGLT2i empagliflosin 25 mg once daily, and the 4th will receive allopurinol and empagliflosin.
- Being tested
- Empagliflozin 25 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 MGDrug
Also called SGLT2 inhibitors
PAtient will receive empagliflozin 25 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | 1st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast | |
| Group 2 | 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily | |
| Group 3 | 3rd group will receive the SGLT2i empagliflosin 25 mg once daily Receives: Drug: Empagliflozin 25 MG | |
| Group 4 | 4thwill receive allopurinol and empagliflosin. Receives: Drug: Empagliflozin 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
SGLT2i proves protective effect
SGLT2i shows protected the kidneys against contrast injury
Measured: 72hours after contrast
Secondary outcomes (1)
SGLT2i is non inferior to allopurinol
SGLT2i showed noninferiorty whencompared to allopurinol
Measured: 72hours after contrast
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SGLT2i Kideny Protection Against Contrast in Diabetic KidneyStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Ahmed Abdelkawi Hammad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853615
- Sponsor's protocol ID
- EC 2119
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is SGLT2 Inhibitors a Better Prophylactic Agent Against Post-contrast Acute Kidney Injury in Diabetic Kidney Disease? A Multicenter Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04853615
- Acronym / sponsor ID
- EC 2119
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 21 Apr 2021 (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.
We will look for the possible effect of SGLT2i as a single agent to prevent post-contrast Acute Kidney Injury in diabetic kidney disease.
Detailed description
Population of Study o Group 1 :
- st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast.
- Group 2 :
- nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily
- Group 3 :
- rd group will receive the SGLT2i empagliflosin 25 mg once daily
- Group 4 :
- thwill receive allopurinol and empagliflosin.
Inclusion Criteria :
- Age: more than30years, diabetes,diabetic kidney disease,GFR: more than30ml/min/1.73m2
Exclusion Criteria :
- Diabetics Patients with GFR less than 30 mL/min/1.73 m2.
Sample Size ( number of participants included ) :
800 patients Fayoum University Faculty of Medicine Scientific Research Ethics Committee
Methodology in details :
The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration. Baseline serum creatinine will be obtained 72 hours before the planned intervention and before administration of any protective protocol and follow-up serum creatinine will be obtained 72 hours and 1 week after contrast administration. The first control group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast. Saline should be given by infusion pump to guarantee steady rate of infusion. 2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily. 3rd group will receive the SGLT2i empagliflosin 25 mg once daily, and the 4th will receive allopurinol and empagliflosin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –1st group will receive normal saline 10ml/kg over 6 hours before and 6 hours after radiocontrast |
| Group 2 | – | –2nd group will receive allopurinol 300 mg and linagliptin 5 mg once daily |
| Group 3 | – | Drug: Empagliflozin 25 MG3rd group will receive the SGLT2i empagliflosin 25 mg once daily |
| Group 4 | – | Drug: Empagliflozin 25 MG4thwill receive allopurinol and empagliflosin. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The chosen patients will be randomly allocated to 4 equal groups that will receive their prophylaxis for 48 hours before and 48 hours after the radiocontrast administration
Key inclusion criteria (1 listed)
- Age: more than30years, Diabetes, Diabetic kidney disease, GFR: more than30ml/min/1.73m2
Key exclusion criteria (1 listed)
- Diabetics Patients with GFR less than 30 mL/min/1.73 m2.
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 |
|---|---|---|
| Empagliflozin 25 MGAlso: SGLT2 inhibitorsPAtient will receive empagliflozin 25 mg daily | Drug | Group 3, Group 4 |
Primary outcome
SGLT2i proves protective effect
Time frame: 72hours after contrast
SGLT2i shows protected the kidneys against contrast injury
1 secondary outcome
SGLT2i is non inferior to allopurinol
Time frame: 72hours after contrast
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: Undecided
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.
Ahmed Fayed, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of SGLT2i Kideny Protection Against Contrast in Diabetic Kidney, run by Fayoum University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Hammad, MD (+201001574639, aah12@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SGLT2i proves protective effect (time frame: 72hours after contrast). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2021.