Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Mar 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how to prevent low blood pressure, known as hypotension, that can happen during hemodialysis in patients with end-stage kidney disease. Researchers believe that a substance called bradykinin, which increases during hemodialysis, may be causing this drop in blood pressure. They want to test a medication called lanadelumab to see if blocking a certain pathway can help prevent these blood pressure drops and improve the overall experience for patients undergoing dialysis.

To participate in this study, you need to be between 18 and 85 years old and have been receiving hemodialysis three times a week for at least six months. You should also have stable blood pressure readings before dialysis and experience significant drops in blood pressure during treatment, which cause symptoms like dizziness or nausea. If you join, you'll be part of a double-blind study, meaning neither you nor the researchers will know if you’re receiving the medication or a placebo (a harmless sugar pill). This trial aims to improve care for patients like you, and your participation could help find better treatments for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects age 18 to 85 years
• • On thrice-weekly hemodialysis for at least six months
• • Clinically stable, adequately dialyzed (single-pool Kt/V \> 1.2), with polysulphone membrane for at least three consecutive months before the study
• • Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
• • Subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmHg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety.
• • Hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions).
• Exclusion Criteria:
• • Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
• • Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
• • History of myocardial infarction or cerebrovascular event within 3 months
• • History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
• • Advanced liver disease
• • Ejection fraction less than 30%
• • Anticipated live donor kidney transplant
• • A history of poor adherence to hemodialysis or medical regimen
• • Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions
• • Use of immunosuppressive drugs within one month before study enrollment
• • Active connective tissue disease
• • History of acute infections disease within one month before study enrollment
• • Inability to provide consent
• • Pregnancy