Renal disease in the final stage MedDRA version: 21.1 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD) System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.0 Level: PT Classification code 10077512 Term: End stage renal disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Difelikefalin
Product Code: [CR845]
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DIFELIKEFALIN
CAS Number: 1024828-77-0
Current Sponsor code: CR845
Other descriptive n
Sponsors
Vifor Fresenius Medical Care Renal Pharma Ltd.
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: To evaluate the PK profile of a single dose of difelikefalin in adolescent subjects aged 12 to 17 years on HD;Secondary Objective: To evaluate the safety and tolerability of a single dose of difelikefalin in adolescent subjects aged 12 to 17 years on HD;Primary end point(s): Pharmacokinetics profile of difelikefalin after a single dose post haemodialysis;Timepoint(s) of evaluation of this end point: Over a 3 day period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of adverse events (AEs) and serious adverse events (SAEs) after a single dose of difelikefalin. Change in vital signs, 12 lead electrocardiogram (ECG), and clinical safety laboratory evaluations after a single dose of difelikefalin;Timepoint(s) of evaluation of this end point: Over 7 days | — |
Countries
Italy, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Vifor Fresenius Medical Care Renal Pharma Ltd.
Outcome results
None listed