Trial Outcomes & Findings for Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (NCT NCT02858726)

Last Updated: 2020-07-29

Results Overview

Intensity of itch was measured using a numerical rating scale (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/PHASE3

Target enrollment

226 participants

Primary outcome timeframe

Baseline, Week 8

Results posted on

2020-07-29

Participant Flow

Of 226 enrolled participants, 175 met inclusion criteria and were randomized to treatment.

Participant milestones

Participant milestones
Measure	CR845 0.5mcg/kg IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)	CR845 1 mcg/kg IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)	CR845 1.5mcg/kg IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)	Placebo IV Placebo administered after each dialysis session (3 times/week)
Overall Study STARTED	44	42	44	45
Overall Study COMPLETED	39	35	33	42
Overall Study NOT COMPLETED	5	7	11	3

Reasons for withdrawal

Reasons for withdrawal
Measure	CR845 0.5mcg/kg IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)	CR845 1 mcg/kg IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)	CR845 1.5mcg/kg IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)	Placebo IV Placebo administered after each dialysis session (3 times/week)
Overall Study Adverse Event	4	4	9	1
Overall Study Physician Decision	0	0	1	0
Overall Study Protocol Violation	0	0	0	1
Overall Study Study Terminated by Sponsor	0	0	0	1
Overall Study Withdrawal by Subject	1	2	1	0
Overall Study Noncompliance	0	1	0	0

Baseline Characteristics

Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CR845 0.5mcg/kg n=44 Participants IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) CR845 0.5 mcg/kg: IV medication delivered three times/week	CR845 1 mcg/kg n=41 Participants IV CR845 1 mcg/kg administered after each dialysis session (3 times/week) CR845 1 mcg/kg: IV medication delivered three times/week	CR845 1.5mcg/kg n=44 Participants IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week) CR845 1.5mcg/kg: IV medication delivered three times/week	Placebo n=45 Participants IV Placebo administered after each dialysis session (3 times/week) Placebo: IV medication delivered three times/week	Total n=174 Participants Total of all reporting groups
Age, Continuous	57.9 years n=5 Participants	58.2 years n=7 Participants	54.1 years n=5 Participants	59.0 years n=4 Participants	57.3 years n=21 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	17 Participants n=4 Participants	69 Participants n=21 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	28 Participants n=5 Participants	28 Participants n=4 Participants	105 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	22 Participants n=7 Participants	31 Participants n=5 Participants	25 Participants n=4 Participants	102 Participants n=21 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	19 Participants n=7 Participants	10 Participants n=5 Participants	16 Participants n=4 Participants	62 Participants n=21 Participants
Race (NIH/OMB) More than one race	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) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 8

Outcome measures

Outcome measures
Measure	CR845 0.5mcg/kg n=44 Participants IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)	CR845 1 mcg/kg n=41 Participants IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)	CR845 1.5mcg/kg n=44 Participants IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)	Placebo n=45 Participants IV Placebo administered after each dialysis session (3 times/week)
Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8	-3.8 score on a scale Standard Error 0.4	-2.8 score on a scale Standard Error 0.4	-3.2 score on a scale Standard Error 0.4	-1.9 score on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: Baseline, Week 8

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. A lower total score represents better quality of life. The minimum score is 0 and the maximum score is 60 (or total score can range from 0 to 60) with a higher score meaning a worse quality of life.

Outcome measures

Outcome measures
Measure	CR845 0.5mcg/kg n=44 Participants IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)	CR845 1 mcg/kg n=41 Participants IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)	CR845 1.5mcg/kg n=44 Participants IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)	Placebo n=45 Participants IV Placebo administered after each dialysis session (3 times/week)
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 8	-18.7 score on a scale Standard Error 2.0	-15.5 score on a scale Standard Error 2.2	-15.1 score on a scale Standard Error 2.3	-8.2 score on a scale Standard Error 2.0

Adverse Events

CR845 0.5mcg/kg

Serious events: 10 serious events

Other events: 22 other events

Deaths: 1 deaths

CR845 1 mcg/kg

Serious events: 6 serious events

Other events: 16 other events

Deaths: 0 deaths

CR845 1.5mcg/kg

Serious events: 11 serious events

Other events: 18 other events

Deaths: 2 deaths

Placebo

Serious events: 4 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	CR845 0.5mcg/kg n=44 participants at risk IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)	CR845 1 mcg/kg n=41 participants at risk IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)	CR845 1.5mcg/kg n=44 participants at risk IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)	Placebo n=45 participants at risk IV Placebo administered after each dialysis session (3 times/week) Placebo: IV medication delivered three times/week
Gastrointestinal disorders Diarrhoea	15.9% 7/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	7.3% 3/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	9.1% 4/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Nervous system disorders Dizziness	13.6% 6/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	7.3% 3/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	4.5% 2/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	4.4% 2/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Gastrointestinal disorders Nausea	11.4% 5/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.4% 1/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Nervous system disorders Somnolence	4.5% 2/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	4.9% 2/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	11.4% 5/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.2% 1/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Injury, poisoning and procedural complications Fall	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	4.9% 2/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	4.5% 2/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Nervous system disorders Headache	0.00% 0/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	12.2% 5/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.2% 1/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Metabolism and nutrition disorders Hyperglycaemia	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.4% 1/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.3% 1/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Nervous system disorders Paraesthesia	2.3% 1/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	4.9% 2/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
General disorders Fatigue	2.3% 1/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.4% 1/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Metabolism and nutrition disorders Hyperkalaemia	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.4% 1/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.3% 1/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Skin and subcutaneous tissue disorders Pruritus	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.4% 1/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.3% 1/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Vascular disorders Hypertension	0.00% 0/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	2.4% 1/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	2.3% 1/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/41 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	6.8% 3/44 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).	0.00% 0/45 • The period of adverse event reporting started after the signing of the ICF through the study follow-up visit or early termination visit (or 7 days after the last dose if no early termination visit was conducted).

Additional Information

Frédérique Menzaghi, PhD

Cara Therapeutics

Phone: 203-406-3700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place