Information for Health Professionals
This information is for health professionals to find out more about the EMPA-KIDNEY study. You can also download a copy of the Participant Information Leaflet and other study documents from the Downloads section.
Information about study design
What is EMPA-KIDNEY?
EMPA-KIDNEY is an international randomized trial initiated and co-ordinated by the Medical Research Council Population Health Research Unit within the Clinical Trial Service Unit and Epidemiological Studies Unit at the University of Oxford. It is testing the effects of empagliflozin 10mg versus placebo on kidney disease progression endpoints and cardiovascular death among patients at risk of progressive chronic kidney disease (CKD). The study aims to recruit 5000 such patients from about 200 hospitals internationally.
There are two phases to the trial:
Participants are given a supply of study treatment and asked to try the pills for 8-12 weeks.
2. Randomization and Follow-up
Provided there are no problems during the Run-in phase and s/he agrees to continue, participants will then be seen again 8-12 weeks after the initial visit. Eligibility will be re-checked and, if the participant remains willing to continue, s/he will then be randomized to receive either empagliflozin 10mg once daily or matching placebo once daily. Study visits will occur at 2 and 6 months and then every 6 months after that. After about 3-4 years, s/he will stop their study treatment 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.
Individualized standard of care: During the study we ask that appropriate management of risk of kidney disease progression, risk of cardiovascular disease, and other conditions which are common in CKD (such as mineral-bone disorder, renal anaemia, metabolic acidosis) are managed in the context of prevailing local, national or international guidance. Support for this can be provided by their normal nephrology or diabetes hospital clinic appointments, but primary care would often be the normal place to co-ordinate care of diabetes, blood pressure, and dyslipidaemia.
Information about empagliflozin
Interacting drugs: There are no known interacting drugs with empagliflozin. It is not thought to interact meaningfully with CYP450 isoforms, P-glycoprotein substrates or common organic anion transporters. In particular, interaction studies conducted in healthy volunteers suggest that empagliflozin had no clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin, warfarin, ramipril, digoxin, diuretics and oral contraceptives.
Relevant side effects: 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 over 8,000 people in trials and that it 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
- Your doctor may notice a kidney function decrease on starting study treatment. This may not be a bad thing as it may be a sign of the protective effect of empagliflozin (or perhaps just natural changes in your kidney function)
- This is an increased risk of a urine or genital tract infection, like candidiasis. These are usually easily treated with a course of antibiotics or antifungals respectively
- 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 study doctor based in Oxford is available on Freefone 0808 164 4060 (24 hours a day, 7 days a week, UK only)
APPLYING FOR ANCILLARY STUDIES
EMPA-KIDNEY is not accepting applications for use of left-over biological samples or exploratory data analyses until completion of the study. An application form for such proposals will be posted on this website in due course.