What side effects are associated with this type of intervention?

Lanadelumab, a plasma kallikrein inhibitor, is being studied for its potential to prevent blood pressure drops during hemodialysis. While specific side effects of lanadelumab in this context are not detailed, similar treatments like icatibant (a bradykinin B2 receptor blocker) have been used to manage blood pressure. Common side effects of such treatments may include injection site reactions, hypersensitivity reactions, and potential mild neurocognitive symptoms. It is important to discuss these potential side effects with a healthcare provider to ensure safe and effective management of low blood pressure.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for the treatment of low blood pressure using plasma kallikrein inhibitors like lanadelumab. However, lanadelumab is being studied for its potential to prevent excessive blood pressure drops during hemodialysis by blocking the bradykinin B2 receptor. This approach is novel, and while other treatments for low blood pressure exist, such as vasopressors and volume expanders, the use of plasma kallikrein inhibitors represents a new potential therapeutic pathway.

What other types of research exist?

One promising alternative to Lanadelumab for treating low blood pressure, especially in the context of hemodialysis-induced hypotension, is Icatibant. Icatibant is a bradykinin B2 receptor antagonist that has shown preliminary success in preventing excessive blood pressure drops during hemodialysis. Another potential option could be the development of other bradykinin pathway modulators or novel agents targeting different aspects of blood pressure regulation, though specific names and details would depend on ongoing research and clinical trial outcomes expected in 2024.

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Plasma Kallikrein Blocker

Lanadelumab for Hemodialysis Complications (Hinder Trial)

Phase 2

Recruiting

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On thrice-weekly hemodialysis for at least six months

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

Must not have

History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months

Advanced liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the second week of the study until the end (week 6)

Summary

This trial tests lanadelumab, a medication that blocks a specific protein in the blood, in patients undergoing hemodialysis who often experience low blood pressure. By blocking this protein, lanadelumab aims to prevent the drop in blood pressure during dialysis.

Who is the study for?

This trial is for adults aged 18-85 with end-stage kidney disease who experience significant blood pressure drops during hemodialysis. Participants must have been on hemodialysis for at least six months, have certain pre-dialytic blood pressure levels, and suffer from symptoms like nausea or dizziness during treatment. They should not be taking immunosuppressants, have recent severe bleeding or heart issues, nor expect a kidney transplant soon.

What is being tested?

The study tests if Lanadelumab Injection can prevent low blood pressure in patients undergoing hemodialysis compared to a placebo. It's a double-blind trial meaning neither the researchers nor participants know who gets the real medicine versus the placebo to ensure unbiased results.

What are the potential side effects?

While specific side effects of Lanadelumab in this context aren't detailed here, common ones may include injection site reactions, pain or bruising; allergic reactions; and possibly increased risk of infections due to its immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on hemodialysis 3 times a week for over 6 months.

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I experience a significant drop in blood pressure and symptoms like nausea or dizziness during dialysis.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had a serious bleeding event in the last 6 months.

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My liver disease is in an advanced stage.

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I am unable to give consent by myself.

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I need medication to manage low blood pressure during dialysis.

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I am expecting to receive a kidney from a living donor.

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I have an active connective tissue disease.

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I need blood transfusions due to severe anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the second week of the study until the end (week 6)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the second week of the study until the end (week 6)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the second week of the study until the end (week 6) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Pressure during hemodialysis

Secondary study objectives

Hypotensive episodes

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LanadelumabExperimental Treatment1 Intervention

Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later

Group II: PlaceboPlacebo Group1 Intervention

Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for low blood pressure often involve mechanisms that stabilize blood pressure by targeting specific pathways. Lanadelumab, a plasma kallikrein inhibitor, works by blocking the kallikrein-kinin system, which is responsible for vasodilation. By inhibiting this pathway, Lanadelumab helps prevent excessive drops in blood pressure, making it particularly useful for patients prone to hypotension, such as those undergoing hemodialysis. This stabilization is crucial for maintaining adequate blood flow and preventing the symptoms and risks associated with low blood pressure.

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