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Anti-Cytokine Therapy for Hemodialysis InflammatION — ACTION  

End-Stage Renal Disease Clinical Trial

Official title:
Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION): A Phase II Multi-center Study to Evaluate the Safety and Tolerability of Anakinra, an IL-1 Receptor Antagonist, for Patients Treated With Maintenance Hemodialysis

Clinical Trial Summary

Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis.

Clinical Trial Description

The ACTION Trial will enroll 80 participants being treated with maintenance hemodialysis for end-stage renal disease. Participants will be randomized to receive Anakinra, 100 mg administered intravenously 3 times per week at the end of the hemodialysis session, or matched placebo. The duration of study drug administration is 24 weeks. There will be an additional 24 weeks of follow-up after study drug administration has been completed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03141983
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase Phase 2
Start date December 15, 2017
Completion date September 2, 2021
View Details
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