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Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

NCT05834777 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-15

No results posted yet for this study

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

Interventions

DRUG

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).

DRUG

Placebo

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

Sponsors & Collaborators

  • Pharvaris Netherlands B.V.

    collaborator INDUSTRY

  • Renal Research Institute

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Jorge L Gamboa, MD/PhD · Vanderbilt University Medical Center

  • Peter Kotanko, MD, FASN · Renal Research Institute

  • Talat A Ikizler, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2026-07-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05834777 on ClinicalTrials.gov