Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT05297786
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
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Notify Me18 year–85 year
All sexes
Interventional
Phase 2
Nashville, Tennessee, 37232, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lanadelumab 300 mg subcutaneous injection
Placebo injection
Time frame: Pre-hemodialysis and post-hemodialysis, up to 4.5 hours, at baseline and at the end of the study (week 6)
Systolic blood pressure pre and post hemodialysis at baseline and at the end of the study
Time frame: From the first week of the study until the end (week 6)
Number of hypotensive episodes during hemodialysis after the initiation of the treatment
Vanderbilt University Medical Center
Other
Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
Acronym: Hinder
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