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CARA Non-Dialysis

Title A Multicenter, Randomized, Double blind, Placebo controlled 12 week Study To Evaluate The Safety And Efficacy Of Oral Difelikefalin In Advanced Chronic Kidney Disease Subjects With Moderate to severe Pruritus And Not On Dialysis With An Up To 52 week Long term Extension.
Therapeutic Area Chronic Kidney Disease, Kidney Diseases, Itching
Principal Investigator Daniel Weiner, MD, MS
Min Age 18 Years
Max Age 85 Years
Gender Any
Contact
617-636-9423
kidneytrials@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05342623

Overview

The purpose of this study is to assess the safety and efficacy of an investigational oral drug called difelikefalin, in reducing the intensity of itching and the impact of itch on your quality of life. The FDA already approved a intravenous(IV) form of the drug to treat moderate-to-severe itchiness in people undergoing hemodialysis. This study continues tests the oral form of the drug in reducing itchiness in people not on dialysis. This study is double blind and placebo controlled, meaning that neither you nor the study team will know if you are assigned to take the real drug or a fake pill. 

Study Details

Inclusion Criteria

  • eGFR ≤20 mL/min/1.73 m2
  • Daily or near-daily itchiness for at least 6 months

Exclusion Criteria

  • On dialysis or have kidney transplant
  • Chronic dehydration

Study Requirements

You could be in this study approximately 70 weeks, which includes a screening period and a 12-week study treatment period followed by an up to 52-week extension study treatment period. You will need to visit the study site approximately 14 times during the study. You may also have two telephone follow-up calls at the end of each study treatment period.