This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.
Screening Period: The Screening Period includes a Screening Visit and a Run-In Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 21 days prior to the start of the Run-in Period. Patients will start the Run-in Period during the week prior to Treatment Period to complete eligibility verification. Treatment Period: All scheduled study visits during the Treatment Period will be conducted on dialysis days. Patients will be administered CR845 as an IV bolus after the end of their dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845 3 times weekly for a total of up to 36 doses. End of treatment (EOT) is defined as the first day of dialysis following the last dose of drug. The EOT procedures will be conducted on the dialysis visit following the last dose of study drug. Follow-up Visit: A final safety Follow up Visit will be conducted 7-10 days after the EOT/Early Termination Visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
222
IV CR845 0.5 mcg/kg administered three times/week
Number of Participants With AEs.
Assessed by monitoring of adverse events.
Time frame: Up to Follow-Up Visit (Week 13-14)
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Cara Therapeutics Study Site
Escondido, California, United States
Cara Therapeutics Study Site
Riverside, California, United States
Cara Therapeutics Study Site
San Diego, California, United States
Cara Therapeutics Study Site
Victorville, California, United States
Cara Therapeutics Study Site
Denver, Colorado, United States
Cara Therapeutics Study Site
Middlebury, Connecticut, United States
Cara Therapeutics Study Site
Norwich, Connecticut, United States
Cara Therapeutics Study Site
Coral Gables, Florida, United States
Cara Therapeutics Study Site
Fort Lauderdale, Florida, United States
Cara Therapeutics Study Site
Hollywood, Florida, United States
...and 37 more locations