Potential side effects of BI 690517
BI 690517 has been studied in an initial trial in about 700 patients with chronic kidney disease for about 14 weeks. That study provided important information on safety of BI 690517 in people with chronic kidney disease that informed the design of EASi-KIDNEYTM and the blood monitoring that is required.
BI 690517 main side effect is that it can cause an elevation in the levels of potassium (K+, a kind of salt) in your blood. Your potassium levels will be checked at every study appointment. High potassium usually does not result in any symptoms. Particularly high potassium can however cause temporary muscle weakness and heart palpitations. If you develop high potassium levels in the blood, the study team will discuss this with you and advise you to modify your diet according to the advice in the accompanying Dietary Potassium Leaflet. The study team may also adjust some of your existing tablets or start additional treatments to manage your potassium if required.
Dehydration can cause a temporary fall in kidney function (known as acute kidney injury). Because of this, it is important that you drink adequate water (especially in hot weather) and alert your doctor if you produce less urine than normal.
Your blood pressure will be monitored at each study visit as the treatment can lower blood pressure. If required, adjustments to other non-study blood pressure treatments might be made by your local study doctors.
We will be monitoring your stress hormone cortisol levels during the trial because BI 690517 could affect your blood cortisol levels. Your blood cortisol levels normally fluctuate daily, peaking in the morning and falling throughout the day. Your blood cortisol levels will be specifically measured in the early morning (ideally before 09:00) at two points in the trial: the one month and three-month follow-up visits (and also if your local doctor requests it). Low cortisol levels can lead to vague non-specific symptoms and can cause fatigue, nausea, low blood pressure (so you may feel dizzy or light-headed) or low blood sugar. High cortisol levels can cause easy bruising, facial redness and stretch marks. If you notice any of these symptoms then please let your usual doctor and/or study team know.
Common everyday symptoms are often included in information medication inserts, and large trials help identify if new pills can increase their likelihood. BI 690517 is a relatively new treatment and so there may be additional side effects we are unaware of.
We will collect information on all possible side effects you experience for at least the first 12 months of the trial (whether the side effects are serious or not). Treatment information leaflets include a wide range of symptoms people might experience whilst taking any pill, and the trial will help us understand better any true side effects of BI 690517. This will include assessment of those currently listed including: cough, nausea (feeling sick), vomiting, diarrhoea or constipation, a fast or abnormal heart rate, difficulty sleeping, altered energy levels, muscle spasms, and back pain. These may not be true side effects, and the trial will help us understand BI 69051) better. For example, many of these symptoms may also happen if you are on the inactive dummy pill (placebo), as they are common in people being treated for a kidney problem or diabetes, and people who are older (ie over 75 years of age). Such groups of people may generally experience more side effects than other groups of people, but they may also have more to gain from any beneficial effects of treatments. EASi-KIDNEYTM will help identify if BI 690517 really causes all of these symptoms.
As with all medicines, some people can develop an allergic reaction, including itchy skin or a skin rash. Very rarely, some people may require emergency treatment for swelling around the mouth and throat causing difficulty in breathing which can even result in death.
Your doctor may also notice that your kidney function slightly decreases. This may actually be a sign of the protective effect of empagliflozin and BI 690517, (or perhaps just natural changes in your kidney function).
Throughout the study, the research team will carefully monitor you and your blood tests for possible side effects. Some side effects may mean that you need to stop taking your study pills temporarily or permanently.
The study research team will keep you up to date with any new important information we learn about the pills.
If you do experience unexpected symptoms and want to ask questions, you can contact your local study research team, or an EASi-KIDNEYTM study doctor based in Oxford, on Freephone 0808 1644060 or +44 (0)808 1644060 from outside the UK (available 24 hours a day, 7 days a week).
If new information is learnt about BI 690517 during the trial, we will share it with you in a new leaflet.