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Can a single shot stop dialysis blood pressure crashes?

NCT ID NCT05297786

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This study tests whether a drug called lanadelumab can prevent sudden drops in blood pressure that often happen during hemodialysis. The trial involves 28 adults on long-term dialysis who are prone to these episodes. Participants receive either the drug or a placebo injection, and researchers monitor blood pressure changes and the number of hypotensive events.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lanadelumab (Takhzyro)
What this could lead to
If it works, this could offer a new way to prevent blood pressure drops during dialysis, making treatment safer and more comfortable for kidney patients.
What could go wrong
This is a small, early-phase trial with only 28 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

28 people

The number who actually took part.

Started

Jul 2022

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

dialysis disequilibrium syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemodialysis complication Hypotension of hemodialysis

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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