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Clinical Trial Summary

This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.


Clinical Trial Description

Double-blind Phase: The Double-blind Phase of the study will consist of a Screening Visit, a 7-day Run-in Period, and a 12-week Double-blind Treatment Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility. Open-label Extension Phase: Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks. The last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination. Follow-up Period: A final safety Follow up Visit will be conducted 7-10 days after the End of Treatment/Early Termination Visit. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03636269
Study type Interventional
Source Cara Therapeutics, Inc.
Contact
Status Completed
Phase Phase 3
Start date July 17, 2018
Completion date March 30, 2020

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