Recruiting
Phase 3

Bradykinin B2 Inhibition

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05834777

Conditions

Intradialytic Hypotension

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Icatibant

Placebo

Study Details

Brief 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.

Conditions

Intradialytic Hypotension

Study ID

NCT05834777

Start date

Dec 11, 2023

Status verified date

Apr, 2026

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Icatibant

153 mL 0.9% saline bag containing 30 mg icatibant acetate (10 mg/ml) IV at each dialysis treatment for four weeks (12 hemodialysis sessions)

placebo comparator: Placebo

153 mL 0.9% saline bag IV at each dialysis treatment at each dialysis treatment for four weeks (12 hemodialysis sessions)

Interventions

Icatibant

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).

Placebo

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

Primary outcome measure

  • Blood pressure during hemodialysis [ Time Frame: 0-8 weeks ]

Central Contacts and Locations

Central contacts

Delia M Woods, BSN/MSL

615-327-7181delia.woods@vumc.org

Locations

Vanderbilt Fresenius

Recruiting

Nashville, Tennessee, United States, 37212

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-04-15.