Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03998163 | CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | PHASE3 | COMPLETED | 222 | — | — | May 6, 2019 | Mar 6, 2020 | Oct 15, 2021 | 47 | United States, Czechia +2 |
| NCT03636269 | CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | PHASE3 | COMPLETED | 473 | — | — | Jul 17, 2018 | Mar 30, 2020 | Apr 26, 2022 | 92 | United States, Australia +9 |
| NCT03422653 | A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1) | PHASE3 | COMPLETED | 378 | — | — | Feb 20, 2018 | Mar 26, 2020 | Apr 26, 2022 | 57 | United States |
| NCT03281538 | Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | PHASE3 | COMPLETED | 288 | — | — | Aug 14, 2017 | Feb 11, 2020 | Oct 14, 2021 | 27 | United States, Puerto Rico |
| NCT02858726 | Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus | PHASE2 | COMPLETED | 226 | — | — | Jun 1, 2016 | Mar 14, 2017 | Jul 29, 2020 | 29 | United States |
Assessed by monitoring of adverse events.
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". LS means estimated percent, odds ratio and P value used a logistic regression model.
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
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.
| Arm | Type | Description |
|---|---|---|
| CR845 0.5mcg/kg | EXPERIMENTAL | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) |
| Placebo | PLACEBO_COMPARATOR | IV Placebo administered after each dialysis session (3 times/week) |
| CR845 1 mcg/kg | EXPERIMENTAL | Part A of study: IV CR845 1 mcg/kg administered after each dialysis session (3 times/week) |
| CR845 1.5mcg/kg | EXPERIMENTAL | Part A of study: IV CR845 1.5 mcg/kg administered after each dialysis session (3 times/week) |
| Name | Type | Description |
|---|---|---|
| CR845 0.5 mcg/kg | DRUG | IV CR845 0.5 mcg/kg administered three times/week |
| Placebo | DRUG | IV placebo administered three times/week |
| CR845 | DRUG | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) |
| CR845 1 mcg/kg | DRUG | IV medication delivered three times/week |
| CR845 1.5mcg/kg | DRUG | IV medication delivered three times/week |
Key Inclusion Criteria: To be eligible for inclusion into the study, a patient must meet the following criteria: * Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening; * Has at least 2 single-pool Kt/V measurements ...