At a glance
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Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
In Brief
A Phase 2 clinical trial evaluating Lanadelumab Injection [Takhzyro] and Placebo for Hemodialysis Complication and Hypotension of Hemodialysis. Completed, enrolled 28 participants across 1 site.
Detailed Summary
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of
Study Details
Timeline
Arms & Interventions
Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later
Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later
Interventions
Lanadelumab 300 mg subcutaneous injection
Placebo injection