Receive our newsletter – data, insights and analysis delivered to you
  1. News
  2. Company News
August 8, 2018

Cara Therapeutics starts dosing in KALM-2 trial

Cara Therapeutics has started dosing patients in the KALM-2 trial, a Phase lll pivotal study of KORSUVA (CR845/difelikefalin) injection to treat haemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).

Cara Therapeutics has started dosing patients in the KALM-2 trial, a Phase lll pivotal study of KORSUVA (CR845/difelikefalin) injection to treat haemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).

The international, multicentre, randomised, double-blind, placebo-controlled, 12-week treatment trial is expected to enrol 350 patients in the US, Europe and some countries in the Pacific Rim region.

The trial intends to examine the safety and efficacy of 0.5mcg/kg CR845/difelikefalin injection in the enrolled patients.

The primary efficacy objective of the KALM-2 trial is the proportion of patients achieving at least a three-point improvement from baseline with respect to the weekly mean of the daily 24‑hour worst itching intensity numeric rating scale (NRS) score at week 12.

“We will continue to focus on patient enrolment in the coming quarters and expect data readouts from both our US and global Phase lll trials in 2019.”

The trial’s secondary objectives are evaluation of itch-related quality of life changes measured using validated self-assessment 5-D Itch and Skindex-10 scales, as well as the proportion of patients obtaining greater than four-point improvement from baseline in weekly mean of the daily 24-hour worst itching intensity NRS score at week 12.

Cara Therapeutics president and CEO Derek Chalmers said: “The initiation of our second Phase lll efficacy trial in dialysis patients with CKD-aP is an important step toward our goal of developing and commercialising KORSUVA injection as a potential novel treatment option for a patient population with significant unmet medical need.

Content from our partners
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide

“We will continue to focus on patient enrolment in the coming quarters and expect data readouts from both our US and global Phase lll trials in 2019.”

KORSUVA has previously received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for use in the treatment of CKD-aP.

No approved therapies are currently available to treat the condition in the US or European Union (EU).

CKD-aP is a difficult systemic itch condition that occurs frequently and at high intensity in patients with chronic kidney disease undergoing hemodialysis and peritoneal dialysis.

Related Companies

Topics in this article:
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU