This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks. This study will consist of a Screening Visit, a 52 week Treatment Period, and a Follow-up Visit. Informed consent will be obtained prior to performing any study-specific procedures. All patients will have a Screening Visit, which can be performed anytime within 14 days prior to the first dose of study drug, to confirm eligibility. Clinical laboratory tests, electrocardiograms (ECGs), vital signs, adverse events, and concomitant medications will be monitored throughout the study. Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit. Blood samples will also be collected periodically for clinical laboratory tests.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
288
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Number of Participants With AEs
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
Time frame: Up to 52 weeks
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Cara Therapeutics Study Site
Chula Vista, California, United States
Cara Therapeutics Study Site
El Centro, California, United States
Cara Therapeutics Study Site
Long Beach, California, United States
Cara Therapeutics Study Site
Northridge, California, United States
Cara Therapeutics Study Site
Denver, Colorado, United States
Cara Therapeutics Study Site
Hollywood, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
Winter Park, Florida, United States
Cara Therapeutics Study Site
Albany, Georgia, United States
Cara Therapeutics Study Site
Augusta, Georgia, United States
...and 17 more locations