CompletedPhase 2

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

United States269 participantsStarted 2018-07-05

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12

Timeframe: Baseline, Week 12

Trial details

NCT IDNCT03617536

SponsorCara Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-24

Results submitted2023-04-25

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