Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cara Therapeutics, Inc.
Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults ≥ 18 years old;
Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.
You may not be if
Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
Is pregnant or nursing;
Has been exposed to any other investigational medication in the past 60 days;
Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
Has a known or suspected allergy to difelikefalin or any component of the investigational product.
