Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT03617536Other idCR845 210301

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 269 participants (actual)
Sponsor: Cara Therapeutics, Inc. · Industry
Design: Randomized · Double masking
Countries: 1 country
United States
Start: 5 Jul 2018
Primary completion: 24 Oct 2019
Completion: 14 Nov 2019
First posted: 6 Aug 2018
Last update posted: 24 Jan 2024
Conditions: Chronic Kidney Diseases · Pruritus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201820192020

Ph 2
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
NCT03617536
5 Jul 2018 to 14 Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

CR845 0.25 mg Oral TabletDrug
CR845 0.5 mg Oral TabletDrug
CR845 1 mg Oral TabletDrug
Placebo Oral TabletDrug

Arms4

Experimental
CR845 0.25 mg Oral Tablet
Oral CR845 0.25 mg to be taken orally once daily for 12 weeks
Experimental
CR845 0.5 mg Oral Tablet
Oral CR845 0.5 mg to be taken orally once daily for 12 weeks
Experimental
CR845 1 mg Oral Tablet
Oral CR845 1 mg to be taken orally once daily for 12 weeks
Placebo comparator
Placebo Oral Tablet
Oral Placebo to be taken orally once daily

Primary outcomes1

Outcomes the sponsor listed as primary.

Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12
Time frame · Baseline, Week 12
Registry description
Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". Higher scores meant worse itch intensity.

Secondary outcomes(3)

Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12
Time frame · Baseline, Week 12
Registry description
The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.
Change From Baseline in 5-D Itch Scale Score at the End of Week 12
Time frame · Baseline, Week 12
Registry description
The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.
Reduction of Itch Intensity as Assessed by the Proportion of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12
Time frame · Week 12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 12

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

Group	Value (score on a scale)
CR845 0.25 mg Oral Tablet	-3.99
CR845 0.5 mg Oral Tablet	-3.84
CR845 1 mg Oral Tablet	-4.42
Placebo Oral Tablet	-3.32

Secondary and other outcome results(3)

Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12

Group	Value (score on a scale)
CR845 0.25 mg Oral Tablet	-21.19
CR845 0.5 mg Oral Tablet	-22.13
CR845 1 mg Oral Tablet	-23.57
Placebo Oral Tablet	-19.95

Secondary outcomeLeast squares mean· Baseline, Week 12

Change From Baseline in 5-D Itch Scale Score at the End of Week 12

Group	Value (score on a scale)
CR845 0.25 mg Oral Tablet	-6.17
CR845 0.5 mg Oral Tablet	-6.84
CR845 1 mg Oral Tablet	-6.97
Placebo Oral Tablet	-5.74

Secondary outcomeNumber· Week 12

Reduction of Itch Intensity as Assessed by the Proportion of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12

Group	Value (percentage of subjects)
CR845 0.25 mg Oral Tablet	66.2
CR845 0.5 mg Oral Tablet	64.8
CR845 1 mg Oral Tablet	72.1
Placebo Oral Tablet	57.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
CR845 0.25 mg Oral TabletOral CR845 0.25 mg to be taken orally once daily for 12 weeks CR845 0.25 mg Oral Tablet: CR845 0.25 mg medication taken orally 1 time/day	0 / 69	9 / 69	12 / 69
CR845 0.5 mg Oral TabletOral CR845 0.5 mg to be taken orally once daily for 12 weeks CR845 0.5 mg Oral Tablet: CR845 0.5 mg medication taken orally 1 time/day	0 / 66	9 / 66	10 / 66
CR845 1 mg Oral TabletOral CR845 1 mg to be taken orally once daily for 12 weeks CR845 1 mg Oral Tablet: CR845 1 mg medication taken orally 1 time/day	1 / 67	9 / 67	15 / 67
Placebo Oral TabletOral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day	3 / 67	5 / 67	8 / 67

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 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: 1. Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period; 2. 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. Exclusion Criteria: 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.

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