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

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.

Timeline

Start

2016-06

Primary completion

2017-03-14

Completion

2017-03-14

Outcome

Met primary endpoint

registry analysis (superiority test); CR845 0.5mcg/kg vs Placebo; p <0.001; Mean Difference (Final Values) -1.8 (95% CI -2.8 to -0.8); Mixed Models Analysis NCT02858726 ↗

Publications

• Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.

Drugs

Indications

No indication recorded.