Actively Recruiting
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study
Led by Vanderbilt University Medical Center · Updated on 2026-04-15
26
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
P
Pharvaris Netherlands B.V.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of icatibant, a drug that blocks the bradykinin B2 receptor, to prevent drops in systolic blood pressure in patients undergoing hemodialysis who frequently experience intradialytic hypotension (IDH). IDH causes a dangerous decline in blood pressure during dialysis, leading to symptoms like cramps, dizziness, and nausea, and is associated with higher mortality due to cardiovascular stress. The study aims to explore whether icatibant can maintain blood pressure and improve quality of life and recovery time after dialysis. Participants will receive either icatibant or a placebo during their hemodialysis sessions in a randomized, double-blind, crossover design. Icatibant is given by intravenous infusion with a pre-infusion dose before dialysis and a maintenance infusion during dialysis, while the placebo group receives a saline infusion at the same rate. Each treatment lasts four weeks, covering 12 dialysis sessions, and is conducted in an outpatient setting using patients' usual dialysis settings. During the study, heart rate and blood pressure will be closely monitored throughout hemodialysis sessions. Researchers will track episodes of hypotension, symptoms related to low blood pressure, and overall quality of life and recovery after dialysis. The study's primary measure is blood pressure stability during dialysis over an 8-week period. Participants' safety and treatment effects will be observed through regular assessments, with the total study duration covering the treatment and monitoring phases.
CONDITIONS
Brief Title
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Patients with end-stage renal disease on hemodialysis or hemodiafiltration for at least 6 months, receiving 3 dialysis sessions per week
- Patients with at least 6 intradialytic hypotension episodes during the last 8 weeks
- Pre-dialysis systolic blood pressure between 110 and 170 mmHg based on two consecutive and averaged measurements
- Patients adequately hemodialyzed with a Kt/V of at least 1.2
- Stable treatment regimen for at least 14 days before dosing, including diet, medications, dry weight, treatment time, dialysate composition and temperature, dialysis shift, blood flow, dialysate flow, and vascular access
- Female patients under 55 years old must agree to use effective contraception during the study and have a negative pregnancy test before starting
- Body weight up to 150 kg
You will not qualify if you...
- Hospitalization within 4 weeks before enrollment, except for vascular access-related hospitalization
- Known clinically evident inflammatory or infectious disease
- Severe anemia with hemoglobin below 8.0 g/dL at screening
- Platelet count below 50 x 10^9/L
- Liver disease with ALT greater than 3 times the upper limit of normal or total bilirubin over 2 times the upper limit with direct bilirubin over 20%
- Known bleeding disorders such as von Willebrand disease or Hemophilia A, B, C
- Recent thromboembolic events within 3 months, including acute coronary syndrome, stroke, or venous thrombosis embolism (except dialysis access thrombosis)
- Recent or planned major surgery within 3 months before screening or during study participation
- Planned living donor kidney transplant during study participation
- Persistent heart failure classified as New York Heart Association class 3 or higher
- Use of antiplatelet therapy other than daily aspirin 150 mg or less
- Use of therapeutic anticoagulation other than standard hemodialysis anticoagulation
- Significant fluid overload defined as more than 5 kg above dry weight
- Life expectancy less than 6 months as judged by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either icatibant or placebo infusions before and during their routine hemodialysis sessions to prevent drops in blood pressure and symptoms related to intradialytic hypotension.
3 hemodialysis sessions per week for 4 weeks (12 sessions total)
Duration - 4 weeks
Participants cross over to receive the alternate treatment (icatibant or placebo) with the same infusion schedule during their routine hemodialysis sessions.
3 hemodialysis sessions per week for 4 weeks (12 sessions total)
Trial Site Locations
Total: 1 location
1
Vanderbilt Fresenius
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
D
Delia M Woods, BSN/MSL
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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