At a glance
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A Two-Part, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
In Brief
A Phase 3 clinical trial evaluating CR845 0.5 mcg/kg, CR845 1 mcg/kg, and 2 other interventions for Uremic Pruritus. Completed, enrolled 226 participants across 29 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
IV medication delivered three times/week
IV medication delivered three times/week
IV medication delivered three times/week
IV medication delivered three times/week