Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

NCT ID: NCT05297786

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-27
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Lanadelumab

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

Group Type: EXPERIMENTAL

Lanadelumab Injection [Takhzyro]

Intervention Type: DRUG

Lanadelumab 300 mg subcutaneous injection

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo injection

Interventions

Lanadelumab Injection [Takhzyro]

Lanadelumab 300 mg subcutaneous injection

Intervention Type: DRUG

Placebo

Placebo injection

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gamboa

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

210633

Identifier Type: -

Identifier Source: org_study_id