NCT05297786

Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hemodialysis Complication
• Hypotension of Hemodialysis

Interventions

Type	Name	Description
DRUG	Lanadelumab Injection [Takhzyro]	Lanadelumab 300 mg subcutaneous injection
DRUG	Placebo	Placebo injection

Timeline

• Start date: 2022-07-27
• Primary completion: 2024-12-30
• Completion: 2026-01-31
• First posted: 2022-03-28
• Last updated: 2026-01-20
• Results posted: 2026-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study