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Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease (Hinder)

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ClinicalTrials.gov Identifier: NCT05297786
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : August 18, 2023
Sponsor:
Information provided by (Responsible Party):
Jorge Gamboa, Vanderbilt University Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Hemodialysis Complication Hypotension of Hemodialysis Drug: Lanadelumab Injection [Takhzyro] Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
Actual Study Start Date : July 27, 2022
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : December 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Lanadelumab
Subjects will receive lanadelumab (300 mg) subcutaneously at the beginning of the study and 14 days later
 Drug: Lanadelumab Injection [Takhzyro]
Lanadelumab 300 mg subcutaneous injection
Placebo Comparator: Placebo
Subjects will receive placebo subcutaneously at the beginning of the study and 14 days later
 Drug: Placebo
Placebo injection


Outcome Measures
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Primary Outcome Measures :
  1. Blood Pressure during hemodialysis [ Time Frame: From the second week of the study until the end (week 6) ]
    Average blood pressure during hemodialysis of three hemodialysis sessions after the second week of treatment.


Secondary Outcome Measures :
  1. Hypotensive episodes [ Time Frame: From the second week of the study until the end (week 6) ]
    Number of hypotensive episodes during hemodialysis after the second week of treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05297786


Contacts
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Contact: Jorge L Gamboa, M.D. Ph.D. 6153434176 jorge.gamboa@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jorge L Gamboa, M.D. Ph.D.    615-343-4176    jorge.gamboa@vanderbilt.edu   
Principal Investigator: Jorge L Gamboa, MD Ph.D         
Principal Investigator: Talat Alp Ikizler, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
More Information
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Responsible Party: Jorge Gamboa, Research Assistant Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT05297786    
Other Study ID Numbers: 210633
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases