Actively Recruiting
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
Led by Vanderbilt University Medical Center · Updated on 2026-04-15
26
Participants Needed
1
Research Sites
150 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
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
Official 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
- End-stage renal disease patients on hemodialysis (including hemodiafiltration) for at least 6 months, with 3 dialysis sessions per week and stable clinical condition
- Patients with at least 6 intradialytic hypotension episodes in the last 8 weeks
- Pre-dialysis systolic blood pressure between 110 and 170 mmHg based on two consecutive measurements
- Adequately hemodialyzed patients with Kt/V of at least 1.2
- Patients with stable treatment regimens for at least 14 days prior to dosing
- Female patients under 55 years agreeing to effective contraception and negative pregnancy test before study start
- Body weight of 150 kg or less
You will not qualify if you...
- Hospitalization within 4 weeks before enrollment, except for vascular access related reasons
- Known inflammatory or infectious disease as per investigator's evaluation
- Severe anemia with hemoglobin less than 8.0 g/dL at screening
- Platelet count below 50 x 10^9/L
- Liver disease with ALT over 3 times the upper limit of normal or total bilirubin over 2 times the upper limit with high direct bilirubin
- Known bleeding disorders such as von Willebrand disease or Hemophilia
- Thromboembolic events within 3 months before screening, excluding dialysis access thrombosis
- Major surgery within 3 months before screening or planned during the study
- Planned living donor kidney transplant during study participation
- Persistent heart failure classified as NYHA class 3 or higher
- Use of antiplatelet therapy other than daily aspirin 150 mg or less
- Therapeutic anticoagulation use other than standard dialysis procedure anticoagulation
- Significant fluid overload more than 5 kg above dry weight
- Life expectancy less than 6 months as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt Fresenius
Nashville, Tennessee, United States, 37212
Actively Recruiting
Research Team
D
Delia M Woods, BSN/MSL
CONTACT
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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