A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus

Completed · Phase 2 · 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 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of study drug).

Key facts

Study ID

NCT03617536

Run by

Cara Therapeutics, Inc.

People needed

269

Starts

2018-07-05

Expected to finish

2019-11-14

Last updated by the study team

2024-01-24

Who can join

Age: 18 and older. 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:
• CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment with estimated GFR <30 mL/min/1.73 m2).
• For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;
• Prior to randomization:
• Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
• Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of 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:
• Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
• Scheduled to receive a kidney transplant during the study;
• New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to screening;
• Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
• Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
• Participated in a previous clinical study with CR845.

Where it is running

• Cara Therapeutics Study Site — Florence, Alabama, United States
• Cara Therapeutics Study Site — Phoenix, Arizona, United States
• Cara Therapeutics Study Site — Prescott, Arizona, United States
• Cara Therapeutics Study Site — Sun City, Arizona, United States
• Cara Therapeutics Study Site — Harrisburg, Arkansas, United States
• Cara Therapeutics Study Site — Bakersfield, California, United States
• Cara Therapeutics Study Site 2 — Bakersfield, California, United States
• Cara Therapeutics Study Site — Canyon Country, California, United States
• Cara Therapeutics Study Site — Escondido, California, United States
• Cara Therapeutics Study Site — Lomita, California, United States
• Cara Therapeutics Study Site — Northridge, California, United States
• Cara Therapeutics Study Site — Riverside, California, United States
• Cara Therapeutics Study Site — Sacramento, California, United States
• Cara Therapeutics Study Site — Whittier, California, United States
• Cara Therapeutics Study Site — Denver, Colorado, United States
• Cara Therapeutics Study Site — Washington D.C., District of Columbia, United States
• Cara Therapeutics Study Site — Edgewater, Florida, United States
• Cara Therapeutics Study Site — Hialeah, Florida, United States
• Cara Therapeutics Study Site — Hollywood, Florida, United States
• Cara Therapeutics Study Site — Lake Worth, Florida, United States
• Cara Therapeutics Study Site 1 — Miami, Florida, United States
• Cara Therapeutics Study Site 2 — Miami, Florida, United States
• Cara Therapeutics Study Site — Ocala, Florida, United States
• Cara Therapeutics Study Site — Orlando, Florida, United States
• Cara Therapeutics Study Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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