Investigating the effect of a new agent on heart disease and kidney function in people who have recovered from acute kidney injury

Phase 3

Recruiting

• Conditions: Heart disease; Acute kidney injury; Cardiovascular - Coronary heart disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12622001467729
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-18
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility, i.e. the ability to recruit and retain participants in the trial until completion. This will be assessed by sites maintaining screening and recruitment logs throughout the duration of the trial[ At completion of the trial];Feasibility, as determined by compliance with the protocol. This includes out of window trial visits as assessed by reviewing protocol deviation records, the number of withdrawals from the trial as assessed by auditing trial consent and withdrawal forms, and reviewing adherence to taking the trial intervention as assessed by participant self-reporting with use of a trial diary along with returned tablet count at the end of the intervention period.[ At 42, 84 and 112 days post-randomisation];Changes in albuminuria levels from baseline assessed by measuring urinary albumin-creatinine ratio (UACR) levels[ At baseline, 42, 84 and 112 days post-randomisation]