Renal Insufficiency, ChronicPhase 4NCT05225077
Short-term Use of Dapagliflozin to Protect Kidney Function in CKD Patients
A Phase 4 study testing Dapagliflozin 10 MG [Farxiga] in people with Renal Insufficiency, Chronic and Cardiac Catheterization, run by Dong-A University at 1 site in South Korea.
Trial summary
This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic, Cardiac Catheterization, Percutaneous Coronary Intervention
- What is being tested?
- Dapagliflozin 10 MG [Farxiga]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2022to 31 Dec 2023
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>18 years
- Written informed consent
- Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 [CKD stage G1-G3]
- Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
Who cannot join
- Active malignancy
- Class I or equivalent indication for treatment with a SGLT2 inhibitor
- Pregnancy or willing of pregnancy during the follow up period
- Active urogenital infection
- Diabetes mellitus type 1
- History of diabetic ketoacidosis
- Cardiogenic shock
- eGFR < 29 ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Dong A University Hospital
Busan, 602-715
Moo Hyun Kim, M.D., +82-51-240-2976, kimmh@dau.ac.kr
About this study
Official title: Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease
This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN.
- Being tested
- Dapagliflozin 10 MG [Farxiga]
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Dapaglifozin, Chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MG [Farxiga]Drug
Dapagliflozin 10 mg once a day for 1 month after CAG or PCI.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10mg group | Active comparator | Dapagliflozin 10 mg once a day for 1 month after the procedure. Receives: Drug: Dapagliflozin 10 MG [Farxiga] |
| Non-intervention group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast induced nephropathy
Serum creatinine (Scr) elevation of >25% or >0.5 mg/dl (44 μmol/l) from baseline within 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies 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
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo Hyun Kim, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225077
- Sponsor's protocol ID
- PROTECT-CKD
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Short-term Dapagliflozin on Renal Function After Heart Catheterization or Percutaneous Coronary Intervention in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05225077
- Acronym / sponsor ID
- PROTECT-CKD
- Keywords
- Sodium-Glucose Transporter 2 Inhibitors, Dapaglifozin, Chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Feb 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.
This study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in CKD patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of CIN.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10mg group | Active comparator | Drug: Dapagliflozin 10 MG [Farxiga]Dapagliflozin 10 mg once a day for 1 month after the procedure. |
| Non-intervention group | No intervention | –No intervention. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18 years
- Written informed consent
- Glomerular Filtration Rate (GFR)≥ 30 ml/min/1.73m2 [CKD stage G1-G3]
- Percutaneous coronary intervention in patients with NSTEMI, UA, STCD and asymptomatic patients
Key exclusion criteria (8 listed)
- Active malignancy
- Class I or equivalent indication for treatment with a SGLT2 inhibitor
- Pregnancy or willing of pregnancy during the follow up period
- Active urogenital infection
- Diabetes mellitus type 1
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 10 MG [Farxiga]Dapagliflozin 10 mg once a day for 1 month after CAG or PCI. | Drug | Dapagliflozin 10mg group |
Primary outcome
Incidence of contrast induced nephropathy
Time frame: 48 hours
Serum creatinine (Scr) elevation of >25% or >0.5 mg/dl (44 μmol/l) from baseline within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
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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.
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 10 MG [Farxiga] in people with Renal Insufficiency, Chronic and Cardiac Catheterization, run by Dong-A University at 1 site in South Korea.
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 8 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 4 Feb 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast induced nephropathy (time frame: 48 hours). 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 4 Feb 2022.