carDIovaScular and renal outCOmes in patients recoVERed from acute kidney injury

The George Institute for Global Health0 sites60 target enrollmentNovember 18, 2022

ConditionsHeart disease Acute kidney injury Cardiovascular - Coronary heart disease Renal and Urogenital - Kidney disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Heart disease
Sponsor: The George Institute for Global Health
Enrollment: 60
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 18, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

The George Institute for Global Health

Eligibility Criteria

Inclusion Criteria

•1\) Adult participants at least 18 years of age
•2\) Pre\-existing diagnosis of albuminuria (defined as urine albumin\-creatinine ratio (UACR) greater than or equal to 30 mg/g)
•3\) Recovered from the previous acute kidney injury (AKI) within the last 30 days. AKI recovery is defined as:
•Complete if the estimated glomerular filtration rate (eGFR) level, at the time of screening for the DISCOVER trial, has returned to within 20% 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
•Complete if the serum creatinine (SCr) level, at the time of screening for the DISCOVER trial, has returned to within 20% 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
•Partial if there is a fall in the Kidney Disease Improving Global Outcomes (KDIGO) AKI stage classification by at least one stage (e.g., from stage 3 to stage 2 AKI, or from stage 2 to stage 1 AKI) when a baseline eGFR and/or SCr value is not available during the 12 months prior to the recent AKI episode
•4\) Recently discharged from hospital or seen in the renal outpatient clinic
•5\) Stable eGFR defined as within 20% of the hospital discharge level or increasing (greater than 20% of discharge levels)
•6\) Expected to be under the care of the participating renal unit for the next 6 months
•7\) 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