Pharmacokinetics and Safety of Difelikefalin in Adolescents on HD

• Research type

  Research Study

• Full title

  An Open-label, Single Arm Study to Evaluate the Pharmacokinetics of a Single Dose of Intravenous Difelikefalin in Adolescents Aged 12 to 17 Years on Haemodialysis

• IRAS ID

  300055

• Contact name

  KOR-PED-201 study team

• Contact email

  KOR-PED-201.study@viforpharma.com

• Sponsor organisation

  Vifor Fresenius Medical Care Renal Pharma Ltd.

• Eudract number

  2021-000894-94

• Duration of Study in the UK

  0 years, 4 months, 13 days

• Research summary

  This study will investigate the pharmacokinetics - PK (how a study medicine is absorbed by and removed from the body) of a single dose of difelikefalin. The study also aims to assess the safety and tolerability (whether any side effects of the study medicine can be handled by patients) of a single dose of difelikefalin for the treatment of pruritus due to chronic kidney disease.

  Difelikefalin is the study medication under investigation and it has not yet been approved by government agencies in any country as a treatment for any condition. Difelikefalin has only been tested in adult volunteers and patients in previous research studies.

  At least 6 young persons (males and females) 12 to 17 years of age, on haemodialysis will take part in this study in United Kingdom and Italy.

  The total study duration for participation is up to 32 days. Participation is voluntary.

  The study will include a:
  • Screening period of up to 21 days a
  • PK period of 3 days including the single dose administration of difelikefalin on Day 1 of the treatment period and a
  • Safety follow-up visit at 7 (up to 10) days post-dosing

  Difelikefalin will be administered intravenously (IV) by injection. Side effects and concomitant medications will be monitored throughout the study. Difelikefalin will be given to participants only during this study.

  Participants will be required to stay at the clinic on those days they are being dialysed in the facility until the required study assessments are completed. Additional visits to the clinic will also be required to complete study assessments.

  Examples of some of the study assessments to be completed during the study include, physical examination, vital signs, 12-lead ECG, blood tests for safety and to measure the amount of study medicine in the body (taken at multiple timepoints).
  

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  21/NW/0170

• Date of REC Opinion

  7 Jun 2021

• REC opinion

  Favourable Opinion