None listed
Conditions
Brief summary
BACKGROUND:- Acute kidney injury (AKI) is a potentially life-threatening condition caused by unsafe levels of fluid and waste products accumulating in the body due to kidneys not working correctly. AKI can occur in when a person is already unwell with another health condition, and so is more common in people who are in hospital. AKI can increase the risk of heart events, further kidney disease and death. Dapagliflozin is a medication that is used to treat people with diabetes, heart disease and kideny disease. Recent studies have shown dapagliflozin to slow the progression of chronic kidney disease, but it has not been investigated in people who have recently recovered from AKI. AIM:- To determine if giving dapagliflozin (10mg in one capsule per day) compared to placebo (a capsule that looks and smells identical but has no active ingredients) reduces kidney injury in people who have sufficiently recovered from AKI. This is a feasibility trial to show whether this trial will be successful before expanding to a larger trial. DESIGN:- The trial will enrol 60 participants from 3 hospitals with in NSW. Participants will be randomised (randomly assigned; like tossing a coin) by a computer to receive either dapagliflozin or placebo for a maximum of 84 days (12 weeks) and followed up for a total of 112 days (16 weeks). This trial is 'double-blinded' which means the doctor and treating team, nor the participant will know which treatment that are receiving.
Interventions
Participants will be randomised to dapagliflozin. Participants will receive 10 mg dapagliflozin, in one oral capsule form, each day for 84 days (12 weeks) from the date of randomisation.
Adherence will be assessed at 6 weeks (self-reported) and 12 weeks (returned capsule count by study coordinator).
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Adult participants at least 18 years of age 2) Sufficient AKI recovery within the last 30 days. Sufficient AKI recovery is defined as one of the following: • The serum creatinine (SCr) level, at the time of screening for the DISCOVER trial, has returned to within 50% of baseline levels as assessed by the median SCr level during the 12 months prior to the recent AKI episode, and excluding SCr values during other instances of AKI. •The SCr level, at the time of screening for the DISCOVER trial, has reduced to equal to or more than 50% from the peak SCr level during the index AKI episode. • The estimated glomerular filtration rate (eGFR) level, at the time of screening for the DISCOVER trial, has returned to within 50% of baseline levels as assessed by the median eGFR level during the 12 months prior to the recent AKI episode, and excluding eGFR values during other instances of AKI. • The eGFR level, at the time of screening for the DISCOVER trial, has increased to equal to or more than 50% from the lowest eGFR level during the index AKI episode. • A fall in the Kidney Disease Improving Global Outcomes (KDIGO) AKI stage classification by at least one stage using the SCr level at the time of screening for the DISCOVER trial 3) Seen in the hospital or at the renal outpatient clinic. 4) Expected to be under the care of the participating renal unit for the next 6 months 5)The treating physician has equipoise on the balance of risk and benefit for the participant in either arm of the study and is willing to randomise participants.
Exclusion criteria
1) Diagnosis of type-1 diabetes mellitus (T1DM) 2) Current use of a sodium glucose cotransporter 2 (SGLT2) inhibitor at the time of screening for the DISCOVER trial 3) Documented SGLT2 inhibitor intolerance 4) Current or ongoing use of contraindicated concomitant medications 5) Severe hepatic impairment, defined as Child-Pugh class C hepatic failure 6) Pregnancy, including breast feeding 7) Patients with diabetic ketoacidosis 8) Advanced CKD with an estimated glomerular filtration rate (eGFR) of less than 25 ml/min/1.73m2 9) Solid organ transplant recipients 10) Participants with cognitive impairment
Outcome results
None listed