RecruitingPhase 3NCT05834777

Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

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

Sponsor

Vanderbilt University Medical Center

Enrollment

26 participants

Start Date

Dec 11, 2023

Study Type

INTERVENTIONAL

Conditions

Intradialytic Hypotension

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

Patients ≥ 18 to ≤ 80 years of age
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
Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks based on medical record assessment
Pre-dialysis systolic blood pressure ≥ 110 and ≤ 170 mmHg assessed by two consecutive and averaged pre-HD blood pressure measurments
Patients adequately hemodialyzed with a Kt/V ≥ 1.2
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)
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
Body weight ≤ 150 kg

Exclusion Criteria14

Patients who have been hospitalized during the last 4 weeks before enrolment, except vascular access related hospitalization
Patients with known clinically evident inflammatory or infectious disease per investigator's evaluation
Severe anemia with a hemoglobin (Hb) < 8.0 g/dL at screening
Platelet count < 50 x 109/L
Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total bilirubin level
Known bleeding disorders e.g., von-Willebrand disease or Hemophilia A, B, C, etc.
Recent (<3 months before screening) thromboembolic event, e.g., acute coronary syndrome, stroke, or venous thrombosis embolism (except dialysis access thrombosis)
Recent (<3 months before screening) major surgery or scheduled major surgery during study participation
Scheduled living donor renal transplant during study participation
Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure
Patients with significant pre-dialysis overload as defined by > 5kg above dry weight estimated by bioimpedance spectroscopy
Patient's life expectancy < 6 months per investigator's judgement

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Interventions

DRUGIcatibant

Icatibant will be administered with an infusion rate of 100µg/kg/h for 15 minutes before their hemodialysis session (pre-infusion) and 50µg/kg/h during their routine hemodialysis session (maintenance infusion).

DRUGPlacebo

0.9% sodium chloride will be administered as the same rate as icatibant