Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

What Was Tested

The trial (phase 3) is built around Icatibant.

Patients suffering from IDH have a higher reported mortality rate due to the given stress on their cardiovascular system.

It had two arms (groups): Icatibant (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

For this purpose, heart rate and blood pressure during hemodialysis are monitored.

Who Took Part

The registry lists 26 planned participants were the target.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients ≥ 18 to ≤ 80 years of age. 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. Body weight ≤ 150 kg.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: 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; platelet count \< 50 x 109/l.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Icatibant group and the comparison group should start out alike.

Each person switched between Icatibant and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Icatibant.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-12-11 with completion listed for 2026-07-01.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

Primary outcome: Blood pressure during hemodialysis (time frame: 0-8 weeks).

It also tracked 2 secondary outcomes, for example Hypotension events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Icatibant in 26 people.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Icatibant compound page, all human trials.