Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus

PHASE2CompletedINTERVENTIONAL
Enrollment

89

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
PruritusUremic Pruritus
Interventions
DRUG

Part A: Placebo

Part A: Single i.v. dose of Placebo administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part A: CR845 0.5 mcg/kg

Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part A: CR845 1.0 mcg/kg

Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part A: CR845 2.5 mcg/kg

Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)

DRUG

Part B: Placebo

Part B: Single i.v. dose of Placebo administered after each dialysis session over a 2 week treatment period (3 times per week)

DRUG

Part B: CR845 1.0 mcg/kg

Part B: Single i.v. dose of CR845 administered after each dialysis session over a 2 week treatment period (3 times per week)

Trial Locations (20)

11365

Trude Weishaupt Memorial Dialysis Center, Fresh Meadows

11501

Winthrop University Hospital, Mineola

27103

Brookview Hills Research Associates, LLC, Winston-Salem

29803

US Renal Care, Aiken

30318

Emory Dialysis Center at Northside, Atlanta

32209

University of Florida College of Medicine Jacksonville, Jacksonville

32809

Orlando Clinical Research Center, Orlando

33028

Pines Clinical Research, Inc., Pembroke Pines

37232

Vanderbilt University Medical Center, Nashville

37408

Southeast Renal Research Institute, Chattanooga

71603

US Renal Care, Pine Bluff

75050

US Renal Care, Grand Prairie

78202

US Renal Care, San Antonio

87301

US Renal Care, Gallup

90806

US Renal Care, Long Beach

91324

Valley Renal Medical Group, Northridge

91773

North American Research Institute, San Dimas

91915

US Renal Care, Chula Vista

92868

Nephrology Specialists Medical Group, Inc, Orange

01107

Western New England Renal & Transplant Associates, PC, Springfield

Sponsors
All Listed Sponsors
lead

Cara Therapeutics, Inc.

INDUSTRY