Acute Kidney InjuryPhase 4DAPA-PCI-AKINCT05435235
Dapagliflozin in the Prevention of Post-Coronary Angioplasty Acute Kidney Injury
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Acute Kidney Injury and Percutaneous Coronary Intervention, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury, Percutaneous Coronary Intervention
- What is being tested?
- Dapagliflozin 10mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to Jun 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or more.
- Scheduled/non-emergent Percutaneous coronary intervention (PCI).
- Post-index procedure Staged PCI with at least 14 days from contrast exposure.
- Patient can fully understand the study information and sign informed consent.
Who cannot join
- Cardiogenic shock /need for inotrope or mechanical pump support.
- Acute kidney injury as defined by KDIGO criteria (<4 weeks) prior to PCI.
- End-Stage Renal Disease prior to PCI (On renal replacement therapy).
- Diabetes Mellitus type 1.
- Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose >400 mg/dl).
- ST-segment elevation Myocardial Infarction undergoing index PCI.
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- Active Genitourinary infection.
- Diagnostic Left Heart Catheterization without PCI.
- Patients undergoing zero contrast PCI.
- Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
- Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
- Patients with Acute Heart Failure admission < 30 days prior to PCI.
- Intercurrent illness resulting in volume depletion and hypotension (MAP<60 mmHg).
- Patients with a kidney transplant.
- Any contrast exposure within 14 days.
- Patients with estimated glomerular filtration rate (eGFR) < 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
- Patients with an active intrinsic inflammatory or autoimmune renal pathology.
- Women of child bearing age (<50 years old).
- Prison Inmates
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury
To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.
- Being tested
- Dapagliflozin 10mg Tab
- Keywords
- SGLT2 inhibitor, Dapagliflozin, AKI, PCI, Angiography
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
One tablet daily starting 48h prior to PCI and continuing for 48h post-PCI.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin arm | Experimental | Patients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI. Receives: Drug: Dapagliflozin 10mg Tab |
| Standard of care | No intervention | Patients who received the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury
According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline which is known or presumed to have occurred within the prior 7 days.
We will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days.
Measured: Within 7 days.
Secondary outcomes (2)
Length of hospital stay
Days
Measured: 7 days
Incidence of genitourinary infections
Symptomatic pyuria or new vaginal infection.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Sep 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Why it stopped: Laboratory UNGAL
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregg Pressman, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435235
- Sponsor's protocol ID
- 2022-864
- Acronym
- DAPA-PCI-AKI
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2022
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dapagliflozin in the Prevention of Post-Coronary Intervention Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT05435235
- Acronym / sponsor ID
- DAPA-PCI-AKI / 2022-864
- Keywords
- SGLT2 inhibitor, Dapagliflozin, AKI, PCI, Angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Laboratory UNGAL
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 28 Jun 2022 (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.
To compare the incidence of acute kidney injury (AKI) post percutaneous coronary intervention (PCI) in a Dapagliflozin treated group versus a group managed with the usual standard of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin arm | Experimental | Drug: Dapagliflozin 10mg TabPatients who received Dapagliflozin 10 mg daily starting 48h prior to PCI and continuing for 48h post-PCI. |
| Standard of care | No intervention | –Patients who received the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or more.
- Scheduled/non-emergent Percutaneous coronary intervention (PCI).
- Post-index procedure Staged PCI with at least 14 days from contrast exposure.
- Patient can fully understand the study information and sign informed consent.
Key exclusion criteria (19 listed)
- Cardiogenic shock /need for inotrope or mechanical pump support.
- Acute kidney injury as defined by KDIGO criteria (<4 weeks) prior to PCI.
- End-Stage Renal Disease prior to PCI (On renal replacement therapy).
- Diabetes Mellitus type 1.
- Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose >400 mg/dl).
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 |
|---|---|---|
| Dapagliflozin 10mg TabOne tablet daily starting 48h prior to PCI and continuing for 48h post-PCI. | Drug | Dapagliflozin arm |
Primary outcome
Acute Kidney Injury
Time frame: Within 7 days.
According to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 definition: increase in serum creatinine by ≥ 0.3 mg/dl (≥ 26.5 μmol/l) within 48 hours or increase in serum creatinine (SCr) to ≥ 1.5 times the known baseline which is known or presumed to have occurred within the prior 7 days. We will measure Urine Neutrophil Gelatinase-associated Lipocalin (UNGAL) at least 6 hours post-PCI and Serum Creatinine at follow up within 7 days.
2 secondary outcomes
Length of hospital stay
Time frame: 7 days
Incidence of genitourinary infections
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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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?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Acute Kidney Injury and Percutaneous Coronary Intervention, run by Albert Einstein Healthcare Network at 1 site in United States.
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 19 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: paused, as of the sponsor's last update on 31 Jul 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Acute Kidney Injury (time frame: Within 7 days.). 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 31 Jul 2024.