A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Chronic Kidney Diseases, Pruritus
In brief
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind 12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.
Key facts
- Study ID
- NCT05342623
- Run by
- Cara Therapeutics, Inc.
- People needed
- 286
- Starts
- 2022-05-17
- Expected to finish
- 2024-02-29
- Last updated by the study team
- 2024-05-07
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be eligible for inclusion into the study, a patient must meet the following criteria:
- Advanced stage 4 and 5 CKD and end stage renal disease on hemodialysis
- Subject self-reports experiencing at least near-daily (eg, most days of a week) pruritus for at least 6 months prior to screening.
- Inadequate response to current or prior treatments (including emollients/moisturizers, topical medications, or systemic treatments) for pruritus prior to screening.
- Prior to randomization on Day 1 of Treatment Period 1:
- Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
- Has a mean baseline WI-NRS score ≥ 5, defined as the average of all non-missing scores reported during the 7-day Run-in Period.
You may not qualify if…
- A patient will be excluded from the study if any of the following criteria are met:
- Scheduled to receive a renal replacement therapy (dialysis or kidney transplant) during the study.
- Has a concomitant disease, significant medical condition or physical/laboratory/ECG/vital signs abnormality that, in the opinion of the investigator, puts the subject at undue risk or interferes with interpretation of study results, impedes completion of the study procedures, or compromises the validity of the study measurements.
- New or change of treatment received for itch, including antihistamines and corticosteroids (oral, intravenous, or topical), within 14 days prior to the start of run-in.
Where it is running
- Cara Therapeutics Study Site — Phoenix, Arizona, United States
- Cara Therapeutics Study Site — Surprise, Arizona, United States
- Cara Therapeutics Study Site — Anaheim, California, United States
- Cara Therapeutics Study Site — Bakersfield, California, United States
- Cara Therapeutics Study Site — Beverly Hills, California, United States
- Cara Therapeutics Study Site — Chula Vista, California, United States
- Cara Therapeutics Study Site — El Centro, California, United States
- Cara Therapeutics Study Site — Garden Grove, California, United States
- Cara Therapeutics Study Site — La Mesa, California, United States
- Cara Therapeutics Study Site — Northridge, California, United States
- Cara Therapeutics Study Site — Ontario, California, United States
- Cara Therapeutics Study Site — Riverside, California, United States
- Cara Therapeutics Study Site — Santa Clara, California, United States
- Cara Therapeutics Study Site — South Gate, California, United States
- Cara Therapeutics Study Site — Tarzana, California, United States
- Cara Therapeutics Study Site — Vacaville, California, United States
- Cara Therapeutics Study Site — Valencia, California, United States
- Cara Therapeutics Study Site — Victorville, California, United States
- Cara Therapeutics Study Site — Arvada, Colorado, United States
- Cara Therapeutics Study Site — Denver, Colorado, United States
- Cara Therapeutics Study Site — New Haven, Connecticut, United States
- Cara Therapeutics Study Site — Atlantis, Florida, United States
- Cara Therapeutics Study Site — Cape Coral, Florida, United States
- Cara Therapeutics Study Site — Coral Gables, Florida, United States
- Cara Therapeutics Study Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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