Chronic Kidney DiseasesNCT06288529
EFFECT SGLT2 INHIBITORS ON CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY
An observational study of Chronic Kidney Diseases and Type2diabetes, run by University of Health Sciences Balikesir Hospital Eduation and Research at 1 site in Turkey (Türkiye).
Trial summary
Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases, Type2diabetes
- How many people
- 975 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 31 Jan 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Total of 975 patients are palanned to be included in our study who underwent coronary artery imaging or percutaneous coronary intervention procedures using CM in three tertiary hospitals. Patient ages between 18 and 75 years and estimated glomerular filtration rates (eGFRs) between 25 and 115 mL/(min•1.73 m2) are palanned to be included in our analyses.
Who may be able to join
- Patients who underwent coronary artery imaging or percutaneous coronary intervention procedures using contrast media
- Patient ages were between 18 and 75 years
- Estimated glomerular filtration rates (eGFRs) between 25 and 115
Who cannot join
- Patients with acute myocardial infarction, acute renal injury, history of kidney transplantation, severe heart failure (HF, New York Heart Association IV), malignancy, also patients who received other PC-AKI preventive medications like as N-acetylcysteine, sodium bicarbonate, or incomplete medical records were excluded from the analyses.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Balikesir Education and Research Hospital
Balıkesir, 10100
About this study
Official title: PROTECTIVE EFFECT OF SGLT2 INHIBITORS ON POST-CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY IN DIABETIC AND CKD PATIENTS
Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.
In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI.
- Conditions
- Chronic Kidney Diseases, Type2diabetes
- Keywords
- Sodium-glucose co-transporter inhibitor, post-contrast acute kidney injury, contrast media, diabetes mellitus, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with type 2 diabetes mellitus using SGLT2 inhibitor | Not described | |
| Patients with type 2 diabetes mellitus not using SGLT2 inhibitor | Not described | |
| Patients with chronic kidney disease mellitus using SGLT2 inhibitor | Not described | |
| Patients with chronic kidney disease mellitus not using SGLT2 inhibitor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of post-contrast acute kidney injury
The impairment of renal function which is measured as either a 25% rise in serum creatinine level from baseline or an increase of 0.5 mg/dL (44 µmol/L) in absolute serum creatinine level.
Measured: Within 48-72 hours following intravenous contrast medium administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start15 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 975 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and Research
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288529
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2023
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROTECTIVE EFFECT OF SGLT2 INHIBITORS ON POST-CONTRAST MEDIUM INDUCED ACUTE KIDNEY INJURY IN DIABETIC AND CKD PATIENTS
- ClinicalTrials.gov ID
- NCT06288529
- Acronym / sponsor ID
- 1
- Conditions
- Chronic Kidney Diseases, Type2diabetes
- Keywords
- Sodium-glucose co-transporter inhibitor, post-contrast acute kidney injury, contrast media, diabetes mellitus, chronic kidney disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 975 participants (actual)
- Lead sponsor
- University of Health Sciences Balikesir Hospital Eduation and ResearchOther government
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 1 Mar 2024 (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.
Chronic kidney disease and type 2 diabetes mellitus patients are with in high-risk patients in coronary arterial diseases and increasing number of coronary angiography and coronary interventional procedures have been performed in these population. As well as the risk factors have been identified by many studies preventive measures are lacking.
In our study we found that SGLT2 inhibitors are beneficial in terms of reducing contrast media induced acute kidney injury in both diabetic and CKD patients.This is one of the leading studies in the literature pointing that SGLT2 inhibitors may have a potentially beneficial role in reducing or preventing the development of PC-AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes mellitus using SGLT2 inhibitor | – | – |
| Patients with type 2 diabetes mellitus not using SGLT2 inhibitor | – | – |
| Patients with chronic kidney disease mellitus using SGLT2 inhibitor | – | – |
| Patients with chronic kidney disease mellitus not using SGLT2 inhibitor | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Total of 975 patients are palanned to be included in our study who underwent coronary artery imaging or percutaneous coronary intervention procedures using CM in three tertiary hospitals. Patient ages between 18 and 75 years and estimated glomerular filtration rates (eGFRs) between 25 and 115 mL/(min•1.73 m2) are palanned to be included in our analyses.
Key inclusion criteria (3 listed)
- Patients who underwent coronary artery imaging or percutaneous coronary intervention procedures using contrast media
- Patient ages were between 18 and 75 years
- Estimated glomerular filtration rates (eGFRs) between 25 and 115
Key exclusion criteria (1 listed)
- Patients with acute myocardial infarction, acute renal injury, history of kidney transplantation, severe heart failure (HF, New York Heart Association IV), malignancy, also patients who received other PC-AKI preventive medications like as N-acetylcysteine, sodium bicarbonate, or incomplete medical records were excluded from the analyses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of post-contrast acute kidney injury
Time frame: Within 48-72 hours following intravenous contrast medium administration.
The impairment of renal function which is measured as either a 25% rise in serum creatinine level from baseline or an increase of 0.5 mg/dL (44 µmol/L) in absolute serum creatinine level.
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 1 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Chronic Kidney Diseases and Type2diabetes, run by University of Health Sciences Balikesir Hospital Eduation and Research at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 1 Mar 2024. 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 Turkey (Türkiye). 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. 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?
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?
Development of post-contrast acute kidney injury (time frame: Within 48-72 hours following intravenous contrast medium administration.). 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 1 Mar 2024.