Patients with chronic kidney disease undergoing hemodialysis pruritus, kidney disease, pediatric CKD, associated pruritus
Conditions
Interventions
Drug: Difelikefalin (CR845)
Difelikefalin (CR845)
KOR agonist
Sponsors
Vifor Fresenius Medical Care Renal Pharma Ltd.
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months and are currently on HD at least 3 times per week. Subjects with or without associated pruritus may enroll. 2. Males or females 12 to 17 years of age, at the time of consent. 3. Has a prescription dry body weight =20 kg and =100 kg.
Exclusion criteria
Exclusion criteria: 1. Known to be non-compliant with HD treatments and deemed unlikely to complete the study by the Investigator (i.e., has a history of missed HD sessions due to non-adherence in the past 2 months). 2. Planned or anticipated to receive a kidney transplant during the study. Note: Being on a kidney transplant list is not an exclusion criterion. 3. Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin greater than 4 × the ULN at screening. 4. Subject has known hypersensitivity to the study drug or any components of the difelikefalin formulation. 5. Known history of allergic reaction to opiates such as hives. Note: Side effects related to the use of opioids such as constipation or nausea would not exclude the subjects from the study. 6. Previous participation in this study. 7. Known or suspected history of alcohol, narcotic, or other drug abuse or substance dependence within 12 months prior to screening. 8. Acute or unstable medical condition(s) which in the opinion of the Investigator would pose undue risk to the subject or would impede complete collection of evaluable data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: PK profile of difelikefalin after a single dose post-HD;Timepoints: Day 1, 2 and 3;Measure: PK sampling | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: Incidence of adverse events (AEs) and serious adverse events (SAEs);Timepoints: From Day 1 to Day 7;Measure: Documentation of all AEs occurred during conduct of study;Name: Incidence of adverse events (AEs) and serious adverse events (SAEs);Timepoints: From Day 1 to Day 7;Measure: Measurement of vital signs, ECG measurements, blood tests | — |
Countries
Italy, Lebanon, United Kingdom
Contacts
Public ContactDiana Salameh
Worldwide Clinical Trials
Outcome results
None listed