Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8
| Group | Value (score on a scale) | Spread |
|---|---|---|
| CR845 0.5mcg/kg | -3.8 | 0.4 |
| CR845 1 mcg/kg | -2.8 | 0.4 |
| CR845 1.5mcg/kg | -3.2 | 0.4 |
| Placebo | -1.9 | 0.4 |
Trial · Interventional
CompletedPhase 2/3Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT02858726Jun 2016 to 14 Mar 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
2 Part Study: Part A will assess 3 different dosing levels of IV CR845 versus placebo in patient on hemodialysis who have moderate-to-severe itching due to uremic pruritus. Patients will receive either CR845 or placebo after each dialysis session for eight weeks. The safety and efficacy of CR845 will be monitored throughout the study. A sub-group of patients will also have pharmacokinetic assessments completed. Part B of the study will assess one dose of IVCR845 versus placebo for 12 weeks in patients on hemodialysis who have moderate-to-severe itching. The dose of CR845 used in Part B will be based on safety and efficacy found in Part A.
Experimental
CR845 0.5mcg/kg
Part A of study: IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Experimental
CR845 1 mcg/kg
Part A of study: IV CR845 1 mcg/kg administered after each dialysis session (3 times/week)
Experimental
CR845 1.5mcg/kg
Part A of study: IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week)
Placebo comparator
Placebo
Part A of study: IV Placebo administered after each dialysis session (3 times/week)
Outcomes the sponsor listed as primary.
Change From Baseline in the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score During Week 8
Time frame · Baseline, Week 8
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.
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
Time frame · 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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (score on a scale) | Spread |
|---|---|---|
| CR845 0.5mcg/kg | -3.8 | 0.4 |
| CR845 1 mcg/kg | -2.8 | 0.4 |
| CR845 1.5mcg/kg | -3.2 | 0.4 |
| Placebo | -1.9 | 0.4 |
| Group | Value (score on a scale) | Spread |
|---|---|---|
| CR845 0.5mcg/kg | -18.7 | 2.0 |
| CR845 1 mcg/kg | -15.5 | 2.2 |
| CR845 1.5mcg/kg | -15.1 | 2.3 |
| Placebo | -8.2 | 2.0 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CR845 0.5mcg/kgIV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) | 1 / 44 | 10 / 44 | 22 / 44 |
| CR845 1 mcg/kgIV CR845 1 mcg/kg administered after each dialysis session (3 times/week) | 0 / 41 | 6 / 41 | 16 / 41 |
| CR845 1.5mcg/kgIV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week) | 2 / 44 | 11 / 44 | 18 / 44 |
| PlaceboIV Placebo administered after each dialysis session (3 times/week) Placebo: IV medication delivered three times/week | 1 / 45 | 4 / 45 | 3 / 45 |
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