Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
Brief 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.


Options:
A: Arm Label: hemodialysis+hemoperfusion (HA330); Type: EXPERIMENTAL; Interventions: Other: hemodialysis only, Other: hemodialysis plus hemoperfusion(HA330) | Arm Label: hemodialysis+hemoperfusion (HA130); Type: EXPERIMENTAL; Interventions: Other: hemodialysis only, Other: hemodialysis plus hemoperfusion(HA130) | Arm Label: hemodialysis only; Type: ACTIVE_COMPARATOR; Interventions: Other: hemodialysis only | Intervention Type: OTHER; Name: hemodialysis only; Assigned to Arm(s): hemodialysis only, hemodialysis+hemoperfusion (HA130), hemodialysis+hemoperfusion (HA330) | Intervention Type: OTHER; Name: hemodialysis plus hemoperfusion(HA330); Assigned to Arm(s): hemodialysis+hemoperfusion (HA330) | Intervention Type: OTHER; Name: hemodialysis plus hemoperfusion(HA130); Assigned to Arm(s): hemodialysis+hemoperfusion (HA130)
B: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nalfurafine HCl 2.5 µg | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nalfurafine HCl 5.0 µg | Intervention Type: DRUG; Name: Nalfurafine HCl 2.5 µg; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Nalfurafine HCl 5.0 µg; Assigned to Arm(s): 3 | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Pregabalin; Type: EXPERIMENTAL; Interventions: Drug: Pregabalin | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): Pregabalin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: CR845 0.5mcg/kg; Type: EXPERIMENTAL; Interventions: Drug: CR845 0.5 mcg/kg | Arm Label: CR845 1 mcg/kg; Type: EXPERIMENTAL; Interventions: Drug: CR845 1 mcg/kg | Arm Label: CR845 1.5mcg/kg; Type: EXPERIMENTAL; Interventions: Drug: CR845 1.5mcg/kg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: CR845 0.5 mcg/kg; Assigned to Arm(s): CR845 0.5mcg/kg | Intervention Type: DRUG; Name: CR845 1 mcg/kg; Assigned to Arm(s): CR845 1 mcg/kg | Intervention Type: DRUG; Name: CR845 1.5mcg/kg; Assigned to Arm(s): CR845 1.5mcg/kg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D