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Completed

NCT Number: NCT05297786

Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanadelumab Injection [Takhzyro]

Drug

Lanadelumab 300 mg subcutaneous injection

Placebo

Drug

Placebo injection

Primary outcomes

  1. Blood Pressure During Hemodialysis

    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

Secondary outcomes

  1. Hypotensive Episodes

    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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein

Acronym: Hinder

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2022
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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