Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus

This study is looking for teenagers aged 12 to 17 who are receiving regular dialysis treatment for long-term kidney disease. You would need to have been on dialysis for at least 12 weeks before joining the study, and your dialysis care must remain steady without changes to how often you have it. Critically, to be considered, you must also be experiencing bothersome itching that is at least 'moderate' to 'severe'. The study team will check this with you using a special rating scale.

There are also some reasons why you might not be able to join. For example, if you're planning to have a kidney transplant soon, or if your itching is caused by something other than your kidney disease (like eczema). You also wouldn't be able to join if you have certain other serious health conditions, especially liver or heart problems, or some types of cancer. The medical team will carefully review all your health information to see if this study is suitable for you.

If you decide to take part in this study, you will receive the study medicine, difelikefalin, either 3 or potentially 4 times a week. This will usually happen during your regular haemodialysis sessions, which means you won't need to make extra trips for the medicine. You will receive the medicine for up to 12 weeks. The entire study period for each participant, including initial checks and follow-up, will last for about 17 to 18 weeks. During this time, you'll continue your usual dialysis visits, where the study team will also do their checks. These checks will include monitoring your safety, asking about your itching, and taking blood samples to see how much of the medicine is in your system.