CR845-CLIN3105_Ph3_Pts with Moderate to Severe Pruritus using CR845
Research type
Research Study
Full title
An open label, multicenter, study to evaluate the safety and effectiveness of intravenous CR845 in hemodialysis patients with moderate-to-severe pruritus
IRAS ID
264219
Contact name
Andrew Davenport
Contact email
Sponsor organisation
Cara Therapeutics Inc.
Eudract number
2018-004572-35
Duration of Study in the UK
0 years, 11 months, 15 days
Research summary
This is a multicentre, open-label research study to test a new investigational medicine called CR845. The main purpose of this study is to see whether CR845 is well tolerated and effective in reducing the intensity of itching in patients with moderate to severe pruritus. Pruritus is a chronic condition in patients with chronic kidney disease (CKD. It involves continuous scratching of the skin leading to significant skin damage. This increases patient’s risk of infection such as cellulitis, sepsis and are at a higher risk of dying (>15%). Large multinational studies have demonstrated that 30-40% of haemodialysis patients have moderate to severe pruritus which has no approved treatment.
CR845 has a novel mechanism of action to relieve itch symptoms by attaching to kappa receptors. A kappa receptor belongs to the family of opioid receptors, including kappa and mu receptors. Typical opioid pain medications attach to mu receptors which is associated with addiction. CR845 is different as it only attaches to kappa receptors outside of the brain and does not produce mu receptor side-effects such as addiction.
Patients eligible for the study are those with end-stage renal disease (ESRD) that receive haemodialysis three times a week and experience moderate to severe pruritus. Approximately, 400 patients may participate in this study lasting up to 18 weeks in 80 different sites in 8 countries (the UK, Czech Republic, Spain, Hungary, Poland, Romania and United States of America).
Patients will visit the research site for screening (up to 21 days before the run-in phase). Patients will be checked for eligibility in the run-in phase (the week before treatment). Patients will receive the drug intravenously after their dialysis sessions, 3 times a week, for 12 weeks. Patients will visit the site 7- 10 days after the end of treatment for a follow up visit.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0996
Date of REC Opinion
9 Sep 2019
REC opinion
Further Information Favourable Opinion