This trial is studying whether the drug difelikefalin can reduce itchiness in CKD patients not on dialysis. The trial has two parts: a 12-week treatment period, and a long-term extension period of up to 52 weeks. The trial is double-blind, meaning that neither the patients nor the doctors know who is receiving the drug or the placebo.
- Chronic Kidney Disease
1 Primary · 4 Secondary · Reporting Duration: Week 12 of Treatment Period 1
Awards & Highlights
2 Treatment Groups
Difelikefalin 1 mg Oral Tablet
1 of 2
Placebo Oral Tablet
1 of 2
400 Total Participants · 2 Treatment Groups
Primary Treatment: Difelikefalin 1 mg Oral Tablet · Has Placebo Group · Phase 3
Who is running the clinical trial?
Age 18 - 85 · All Participants · 2 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
What are some of the possible side effects of taking Difelikefalin 1 mg Oral Tablet?
"We believe that Difelikefalin 1 mg Oral Tablet is safe, as it has received a 3 on our 1-3 scale. This is a Phase 3 trial, so there is evidence of efficacy and multiple rounds of data supporting safety." - Anonymous Online Contributor
Are there any availability for new participants in this trial?
"The website clinicaltrials.gov shows that this study is still open to enrolling patients. This trial was first publicized on May 17th, 2022 and was last updated on September 28th of the same year." - Anonymous Online Contributor
How many human participants are allowed in this experiment?
"The sponsor, Cara Therapeutics, Inc., needs to recruit 400 eligible patients from various sites - including Cara Therapeutics Study Sites in Chattanooga, Tennessee and Cara Therapeutics Study Site 2 in Coral Gables, Florida - to fulfil the requirements of the clinical trial." - Anonymous Online Contributor
Does this clinical trial have a broad reach in Canada?
"This study is running at a total of 34 sites, some of which include Chattanooga, Coral Gables and Greenville. If you enroll in the study, it would be beneficial to choose a location nearest to you in order to limit travel time and expenses." - Anonymous Online Contributor
If a patient is over 35 years old, can they still enroll in this research project?
"This study includes people aged 18-85, as per the eligibility requirements." - Anonymous Online Contributor
Are there any exclusionary factors for this particular trial?
"To qualify for this study, participants must suffer from pruritus and be between 18-85 years old. The trial is looking to enroll 400 individuals in total." - Anonymous Online Contributor