RECRUITING

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

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Conditions

Intradialytic HypotensionHemodialysisBradykininKallikrein-Kinin SystemIcatibant

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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

Currently, there is no medication available to adequately treat patients undergoing hemodialysis who are suffering from intradialytic hypotension (IDH). Medical interventions such as Trendelenburg positioning, saline bolus administration, reduction of ultrafiltration rate, interruption of the hemodialysis, and other medical treatments are the methods of choice to treat the hypotensive condition of these patients and thus to maintain the systolic blood pressure. Patients suffering from IDH have a higher reported mortality rate due to the given stress on their cardiovascular system. New treatments, therefore, would give clinicians an additional alternative to current existing approaches and might help patients to maintain their blood pressure during hemodialysis. The main objective of the study is to evaluate the efficacy of icatibant in the prevention of systolic blood pressure (SBP) drop in patients on hemodialysis suffering from recurrent IDH episodes during hemodialysis.

Official Title

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study

Quick Facts

Study Start:2023-12-11
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05834777

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients ≥ 18 to ≤ 80 years of age
  2. * Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for at least 6 months, receiving 3 dialysis sessions per week and who are in a stable clinical condition per investigator's judgement
  3. * Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks based on medical record assessment
  4. * Pre-dialysis systolic blood pressure ≥ 110 and ≤ 170 mmHg assessed by two consecutive and averaged pre-HD blood pressure measurments
  5. * Patients adequately hemodialyzed with a Kt/V ≥ 1.2
  6. * Patients whose treatment regimen remained unchanged within 14 days prior to dosing (diet, medication, dry weight, treatment time, dialysate composition and temperature, dialysis shift, blood flow, and dialysate flow, vascular access)
  7. * Female subjects \< 55 years of age to agree on effective contraception methods throughout the study period and who have a negative pregnancy test before initiating study activities
  8. * Body weight ≤ 150 kg
  1. * Patients who have been hospitalized during the last 4 weeks before enrolment, except vascular access related hospitalization
  2. * Patients with known clinically evident inflammatory or infectious disease per investigator's evaluation
  3. * Severe anemia with a hemoglobin (Hb) \< 8.0 g/dL at screening
  4. * Platelet count \< 50 x 109/L
  5. * Hepatic disease associated with ALT \> 3x ULN, or total bilirubin \>2x ULN with direct bilirubin \> 20% of the total bilirubin level
  6. * Known bleeding disorders e.g., von-Willebrand disease or Hemophilia A, B, C, etc.
  7. * Recent (\<3 months before screening) thromboembolic event, e.g., acute coronary syndrome, stroke, or venous thrombosis embolism (except dialysis access thrombosis)
  8. * Recent (\<3 months before screening) major surgery or scheduled major surgery during study participation
  9. * Scheduled living donor renal transplant during study participation
  10. * Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
  11. * Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
  12. * Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure
  13. * Patients with significant pre-dialysis overload as defined by \> 5kg above dry weight estimated by bioimpedance spectroscopy
  14. * Patient's life expectancy \< 6 months per investigator's judgement

Contacts and Locations

Study Contact

Delia M Woods, BSN/MSL
CONTACT
615-327-7181
delia.woods@vumc.org

Principal Investigator

Jorge L Gamboa, MD/PhD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Peter Kotanko, MD, FASN
PRINCIPAL_INVESTIGATOR
Renal Research Institute
Talat A Ikizler, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt Fresenius
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Jorge L Gamboa, MD/PhD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center
  • Peter Kotanko, MD, FASN, PRINCIPAL_INVESTIGATOR, Renal Research Institute
  • Talat A Ikizler, MD, PRINCIPAL_INVESTIGATOR, 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 Date2023-12-11
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Hemodialysis
  • Intradialytic hypotension
  • Bradykinin
  • Kallikrein-Kinin System
  • Icatibant

Additional Relevant MeSH Terms

  • Intradialytic Hypotension