A randomized, double-blind, placebo-controlled study of oral difelikefal in advanced ckd & pruritus

• Research type

  Research Study

• Full title

  A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED 12-WEEK STUDY TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF ORAL DIFELIKEFALIN IN SUBJECTS WITH ADVANCED CHRONIC KIDNEY DISEASE AND MODERATE-TO-SEVERE PRURITUS WITH A 24-WEEK OPEN-LABEL EXTENSION

• IRAS ID

  1008469

• Contact name

  Frédérique Menzaghi

• Sponsor organisation

  Cara Therapeutics, Inc.

• Research summary

  This is a double-blind, randomized, placebo-controlled, multicenter study to evaluate the Pharmacokinetics, Pharmacodynamics, exposure-response relationship, and safety of oral difelikefalin in subjects with advanced chronic kidney disease (CKD) and moderate-to-severe pruritus. The study includes a Double-blind Treatment Period, an Open-label Extension Period, and a Follow-up Period. Participants will be randomly assigned in a 1:1:1 ratio to receive once daily oral difelikefalin tablets at a dose of 0.5 mg, 1 mg, or placebo over 12 weeks. Participants who complete the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will be entitled to receive open-label difelikefalin at a dose of 1 mg for an additional 24 weeks. Day 1 of the Open-label Extension Period can occur immediately on the day after the last visit of the Double-blind Treatment Period or up to 1 week following the Double-blind Treatment Period. Approximately 210 participants (70 per treatment group) with advanced CKD will be enrolled in the study.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0816

• Date of REC Opinion

  27 Nov 2023

• REC opinion

  Further Information Favourable Opinion