Phase 3_CR845 in Hemodialysis Patients with Pruritus
Research type
Research Study
Full title
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS CR845 IN HEMODIALYSIS PATIENTS WITH MODERATE-TO-SEVERE PRURITUS, WITH A 52-WEEK OPEN-LABEL EXTENSION
IRAS ID
238899
Contact name
Kieran McCaferty
Contact email
Sponsor organisation
Cara Therapeutics INC
Eudract number
2018-001930-17
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
This study is a phase III study for hemodialysis patients with moderate to severe pruritus and have itching associated with chronic kidney disease (also known as “uremic pruritus”).
Uremic pruritus is a chronic, unremitting, and highly bothersome condition in patients with chronic kidney disease that adversely affects sleep, mood, and ability to socialise. Patients with uremic pruritus frequently exhibit considerable mechanical skin damage because of continuous scratching with excoriations, superimposed infections, and chronic lesions of prurigo nodularis( Itchy nodules) or skin lichenification (skin condition that occurs in response to excessive itching or rubbing of the skin and results in thick, leathery patches of skin) often occurring.
The study involves a study drug called CR845 which has a novel mechanism of action to relieve itch symptoms by attaching to kappa receptors.
This is a multicentere, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a Double-blind Phase and an Open-label Extension Phase.The CR845 will be evaluated relative to placebo over a 12 week Double-blind Treatment Period in hemodialysis patients with moderate-to-severe pruritus. At the end of the Double-blind Treatment Period, patients who received at least 30 doses of study drug during the 12-week Double-blind Treatment Period will be eligible to receive open-label CR845 for an additional 52 weeks. A follow-up visit will be conducted 7-10 days after the last study visit on treatment or after early termination.
Up to 500 patients may participate in this study.The participation in this study will last up to 70 weeks.REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/1559
Date of REC Opinion
5 Nov 2018
REC opinion
Further Information Favourable Opinion