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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02229929 | Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus | PHASE2 | COMPLETED | 89 | — | — | Jul 1, 2014 | Jul 1, 2015 | Aug 10, 2016 | 20 | United States |
To evaluate the pharmacokinetics of repeated doses of CR845 in hemodialysis patients over a one-week treatment period.
Change from baseline to the average of Week 2 worst itching (daytime and nighttime) VAS where 0 mm represents "No Itch" and 100 mm represents the "Worst Itch You Can Imagine".
| Arm | Type | Description |
|---|---|---|
| Part A: Placebo | PLACEBO_COMPARATOR | Intravenous matched placebo |
| Part A: CR845 0.5 mcg/kg | EXPERIMENTAL | Intravenous CR845, 0.5 mcg/kg |
| Part A: CR845 1.0 mcg/kg | EXPERIMENTAL | Intravenous CR845, 1.0 mcg/kg |
| Part A: CR845 2.5 mcg/kg | EXPERIMENTAL | Intravenous CR845, 2.5 mcg/kg |
| Part B: Placebo | PLACEBO_COMPARATOR | Intravenous matched placebo |
| Part B: CR845 1.0 mcg/kg | EXPERIMENTAL | Intravenous CR845, 1.0 mcg/kg |
| Name | Type | Description |
|---|---|---|
| Part A: Placebo | DRUG | Part A: Single i.v. dose of Placebo administered after each dialysis session over a 1 week treatment period (3 times per week) |
| Part A: CR845 0.5 mcg/kg | DRUG | Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week) |
| Part A: CR845 1.0 mcg/kg | DRUG | Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week) |
| Part A: CR845 2.5 mcg/kg | DRUG | Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week) |
| Part B: Placebo | DRUG | Part B: Single i.v. dose of Placebo administered after each dialysis session over a 2 week treatment period (3 times per week) |
| Part B: CR845 1.0 mcg/kg | DRUG | Part B: Single i.v. dose of CR845 administered after each dialysis session over a 2 week treatment period (3 times per week) |
Inclusion criteria: * Able to provide written informed consent prior to any study procedures; * Able to communicate clearly with the Investigator and staff, able to read and understand the study procedures; * Males or females 18 years of age or older; * End stage renal disease (ESRD) patients who h...