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ACTIVE NOT RECRUITING
NCT05297786
PHASE2

Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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

Official title: Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2022-07-27

Completion Date

2026-01-31

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DRUG

Lanadelumab Injection [Takhzyro]

Lanadelumab 300 mg subcutaneous injection

DRUG

Placebo

Placebo injection

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States