ACTIVE_NOT_RECRUITING

Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein

Quick Facts

Study Start:2022-07-27
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05297786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects age 18 to 85 years
  2. * On thrice-weekly hemodialysis for at least six months
  3. * Clinically stable, adequately dialyzed (single-pool Kt/V \> 1.2), with polysulphone membrane for at least three consecutive months before the study
  4. * Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
  5. * 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.
  6. * Hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions).
  1. * Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
  2. * Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
  3. * History of myocardial infarction or cerebrovascular event within 3 months
  4. * History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
  5. * Advanced liver disease
  6. * Ejection fraction less than 30%
  7. * Anticipated live donor kidney transplant
  8. * A history of poor adherence to hemodialysis or medical regimen
  9. * Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions
  10. * Use of immunosuppressive drugs within one month before study enrollment
  11. * Active connective tissue disease
  12. * History of acute infections disease within one month before study enrollment
  13. * Inability to provide consent
  14. * Pregnancy

Contacts and Locations

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-27
Study Completion Date2025-08

Study Record Updates

Study Start Date2022-07-27
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Hemodialysis Complication
  • Hypotension of Hemodialysis