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Health professionals

Information for clinicians

EASi-KIDNEYTM is an international randomised trial initiated and co-ordinated by the Renal Studies Group at the University of Oxford.

It is testing the effects of vicadrostat, also known as BI 690517, 10mg versus placebo, together with study-provided empagliflozin 10mg once daily, on a primary composite outcome of kidney disease progression, hospitalization for heart failure and cardiovascular death among patients at risk of progressive chronic kidney disease.

The study aims to recruit about 11,000 such patients from about 450 hospitals internationally. There are two phases to the trial:

1. run-in

Participants will initially be started on or switched to study-provided empagliflozin 10mg daily and has been given a supply of study treatment to try for 8-15 weeks. Read the run-in letter sent to GPs.

2. randomisation and follow-up

Provided there are no problems during the run-in phase and they agree to continue, participants will then be seen again at least eight weeks after the initial visit. Eligibility will be re-checked and, if they remain willing to continue, they will then be randomised to receive either vicadrostat (BI 690517) 10mg once daily or matching placebo once daily, and a study-provided supply of empagliflozin 10mg once daily. An appointment will be scheduled for local early morning blood tests at about four weeks’ time. Study visits will occur at three and six months after randomisation and then every six months after that. After about three - four years, they will stop their study treatment and study-provided empagliflozin and the trial results will be analysed and published. 

The study is double-blind so participants and investigators do not know which treatment participants are allocated. 

Vicadrostat (BI 690517) increases potassium. This will be monitored in the trial, and may require changes to their non-study medication (e.g. to improve glycaemic or acidosis control, alter other potassium increasing medication, start potassium binders). This is the responsibility of the local investigators at the participants' trial site. Read the randomisation letter sent to GPs.

interacting drugs

There are no known interacting drugs with empagliflozin. Exploratory analyses in the Phase II study revealed that neither empagliflozin affected vicadrostat (BI 690517) exposure levels or vice versa.

Vicadrostat (BI 690517) is glucuronidated by uridine 5′-diphosphate glucuronyltransferases (UGT) UGT2B7 and UGT2B4. As such, concomitant administration of medications that are known to inhibit UGT (probenecid, valproic acid, fluconazole, amitriptyline, clomipramine) should be used with caution (but are not contraindicated). Also note that rifampin and phenytoin can induce UGT, potentially decreasing vicadrostat (BI 690517) concentrations. 

relevant side effects

Vicadrostat (BI 690517) is a newly developed medication which has only been tested in a limited number of people to date and so has not yet been approved as a treatment for any disease. It is explained to participants when they consent for the trial that:

  • Vicadrostat (BI 690517) has been tested in clinical trials with healthy volunteers and in around 700 patients with kidney disease to determine the most appropriate dosage to use in large trials like EASi-KIDNEYTM
  • There is a risk of hyperkalaemia, a predictable effect of inhibiting the aldosterone pathway, and it may be necessary for participants to modify their diet (a Low Potassium Diet Information Leaflet has been provided.)
  • Hypotension may occur, and it may be necessary to change blood pressure medication to compensate
  • Participants’ morning cortisol levels may be affected. No symptomatic episodes of low serum cortisol and no adrenal crises were reported in the phase II trial in ~700 participants with CKD. Participants’ cortisol levels will be monitored early in the trial.
  • A kidney function decrease on starting study treatment may be noticed. This may not be a bad thing as it may be a sign of the protective effect of vicadrostat (BI 690517, or perhaps just natural changes in the participants’ kidney function).

Empagliflozin is a marketed drug and more complete details are available in the Summary of Product Characteristics. It is explained to participants when they consent for the trial that:

  • Empagliflozin has already been tested in thousands of people in trials of a range of conditions and has been generally well-tolerated.
  • There is a risk of polyuria, increased thirst and other symptoms of dehydration, and that it may be necessary to change blood pressure/diuretic medication to compensate.
  • This is an increased risk of a urine or fungal genital tract infection, like candidiasis. These are usually easily treated with a course of antibiotics or antifungals respectively, but be aware that necrotizing fasciitis has been reported. If the patient develops perineal pain, please ensure rapid assessment and care.
  • Hypoglycaemia may also occur, particularly in people on insulin or sulphonylureas.
  • For people with diabetes, ketoacidosis can develop without blood sugars being particularly high (“normoglycaemic” ketoacidosis). Those at highest risk are those with type 1 diabetes and those with type 2 requiring insulin.
  • A kidney function decrease on starting study treatment may be noticed. This may not be a bad thing as it may be a sign of the protective effect of empagliflozin and vicadrostat (BI 690517, or perhaps just natural changes in the participants’ kidney function).