View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
  2. Company News
August 8, 2018updated 12 Jul 2022 1:13pm

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).

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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.

“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

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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

Thank you for subscribing to Clinical Trials Arena