The purpose of this study is to assess the safety and efficacy of an investigational oral drug called difelikefalin, in reducing the intensity of itching and the impact of itch on your quality of life. The FDA already approved a intravenous(IV) form of the drug to treat moderate-to-severe itchiness in people undergoing hemodialysis. This study continues tests the oral form of the drug in reducing itchiness in people not on dialysis. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill.
- Daily or near-daily itchiness for at least 6 months
- On dialysis or have kidney transplant
- Chronic dehydration
You could be in this study approximately 70 weeks, which includes a screening period and a 12-week study treatment period followed by an up to 52-week extension study treatment period. You will need to visit the study site approximately 14 times during the study. You may also have two telephone follow-up calls at the end of each study treatment period.