Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus (NCT NCT03617536)

Last Updated: 2024-01-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

269 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2024-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	CR845 0.25 mg Oral Tablet Oral 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	CR845 0.5 mg Oral Tablet Oral 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	CR845 1 mg Oral Tablet Oral 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	Placebo Oral Tablet Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day
Overall Study STARTED	69	66	67	67
Overall Study COMPLETED	60	57	54	57
Overall Study NOT COMPLETED	9	9	13	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CR845 0.25 mg Oral Tablet n=69 Participants Oral 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	CR845 0.5 mg Oral Tablet n=66 Participants Oral 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	CR845 1 mg Oral Tablet n=67 Participants Oral 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	Placebo Oral Tablet n=67 Participants Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day	Total n=269 Participants Total of all reporting groups
Age, Continuous	65.7 years STANDARD_DEVIATION 11.0 • n=5 Participants	69.0 years STANDARD_DEVIATION 12.0 • n=7 Participants	67.5 years STANDARD_DEVIATION 10.7 • n=5 Participants	65.6 years STANDARD_DEVIATION 12.1 • n=4 Participants	66.9 years STANDARD_DEVIATION 11.5 • n=21 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	33 Participants n=7 Participants	32 Participants n=5 Participants	30 Participants n=4 Participants	130 Participants n=21 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	33 Participants n=7 Participants	35 Participants n=5 Participants	37 Participants n=4 Participants	139 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	17 Participants n=4 Participants	61 Participants n=21 Participants
Race (NIH/OMB) White	49 Participants n=5 Participants	49 Participants n=7 Participants	48 Participants n=5 Participants	47 Participants n=4 Participants	193 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Outcome measures

Outcome measures
Measure	CR845 0.25 mg Oral Tablet n=69 Participants Oral 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	CR845 0.5 mg Oral Tablet n=66 Participants Oral 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	CR845 1 mg Oral Tablet n=67 Participants Oral 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	Placebo Oral Tablet n=67 Participants Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day
Change From Baseline in Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score During Week 12	-3.99 score on a scale Interval -4.62 to -3.36	-3.84 score on a scale Interval -4.5 to -3.18	-4.42 score on a scale Interval -5.08 to -3.76	-3.32 score on a scale Interval -3.97 to -2.68

SECONDARY outcome

Timeframe: Baseline, Week 12

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.

Outcome measures

Outcome measures
Measure	CR845 0.25 mg Oral Tablet n=69 Participants Oral 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	CR845 0.5 mg Oral Tablet n=66 Participants Oral 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	CR845 1 mg Oral Tablet n=67 Participants Oral 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	Placebo Oral Tablet n=67 Participants Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day
Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12	-21.19 score on a scale Interval -24.34 to -18.04	-22.13 score on a scale Interval -25.37 to -18.89	-23.57 score on a scale Interval -27.0 to -20.14	-19.95 score on a scale Interval -23.17 to -16.73

SECONDARY outcome

Timeframe: Baseline, Week 12

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.

Outcome measures

Outcome measures
Measure	CR845 0.25 mg Oral Tablet n=69 Participants Oral 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	CR845 0.5 mg Oral Tablet n=66 Participants Oral 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	CR845 1 mg Oral Tablet n=67 Participants Oral 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	Placebo Oral Tablet n=67 Participants Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day
Change From Baseline in 5-D Itch Scale Score at the End of Week 12	-6.17 score on a scale Interval -7.1 to -5.25	-6.84 score on a scale Interval -7.78 to -5.9	-6.97 score on a scale Interval -7.97 to -5.97	-5.74 score on a scale Interval -6.69 to -4.8

SECONDARY outcome

Timeframe: Week 12

Outcome measures

Outcome measures
Measure	CR845 0.25 mg Oral Tablet n=69 Participants Oral 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	CR845 0.5 mg Oral Tablet n=66 Participants Oral 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	CR845 1 mg Oral Tablet n=67 Participants Oral 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	Placebo Oral Tablet n=67 Participants Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day
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	66.2 percentage of subjects Interval 53.0 to 77.32	64.8 percentage of subjects Interval 51.18 to 76.3	72.1 percentage of subjects Interval 58.62 to 82.45	57.9 percentage of subjects Interval 44.15 to 70.49

Adverse Events

CR845 0.25 mg Oral Tablet

Serious events: 9 serious events

Other events: 12 other events

Deaths: 0 deaths

CR845 0.5 mg Oral Tablet

Serious events: 9 serious events

Other events: 10 other events

Deaths: 0 deaths

CR845 1 mg Oral Tablet

Serious events: 9 serious events

Other events: 15 other events

Deaths: 1 deaths

Placebo Oral Tablet

Serious events: 5 serious events

Other events: 8 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CR845 0.25 mg Oral Tablet n=69 participants at risk Oral 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	CR845 0.5 mg Oral Tablet n=66 participants at risk Oral 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	CR845 1 mg Oral Tablet n=67 participants at risk Oral 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	Placebo Oral Tablet n=67 participants at risk Oral Placebo to be taken orally once daily Placebo Oral Tablet: Placebo tablet taken orally 1 time/day
Metabolism and nutrition disorders Hyperkalaemia	4.3% 3/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	1.5% 1/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	3.0% 2/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	6.0% 4/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).
General disorders Fatigue	5.8% 4/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	1.5% 1/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	4.5% 3/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	1.5% 1/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).
Vascular disorders Hypertension	5.8% 4/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	0.00% 0/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	1.5% 1/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	1.5% 1/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	6.1% 4/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	0.00% 0/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	0.00% 0/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).
Gastrointestinal disorders Constipation	2.9% 2/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	3.0% 2/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	6.0% 4/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	3.0% 2/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).
Gastrointestinal disorders Diarrhoea	2.9% 2/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	3.0% 2/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	6.0% 4/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	1.5% 1/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).
Nervous system disorders Dizziness	0.00% 0/69 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	3.0% 2/66 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	7.5% 5/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).	0.00% 0/67 • Adverse events were recorded starting at the Screening Visit and continuing through the Follow-up Visit (7 to 10 days after the last dose of study drug).

Additional Information

Director of Clinical Trials

Cara Therapeutics

Phone: 203-406-3700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place