Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
StatusRecruiting
PhasePhase 3
Started2023-12-11
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 15, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
Amendment history
2026-04-10
minor
Study Status v5
Primary completion date2026-02-01→2026-07-01
Completion date2026-04-01→2026-11-01
2025-01-07
minor
Study Status v4
Primary completion date2025-09-01→2026-02-01
Completion date2025-12-01→2026-04-01
2023-12-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-11-01→confirmed 2023-12-11
Study sites0→1
2023-09-29
minor
Study Status v2
Start date2023-09-01→2023-11-01
2023-07-27
minor
Study Status v1
Start date2023-06-01→2023-09-01
2023-04-17
minor
Original filing
320 trials monitored
See 25 trials at risk
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.
| NCT Number |
NCT05834777 |
| Lead Sponsor |
Vanderbilt University Medical Center
Collaborators: Pharvaris Netherlands B.V., Renal Research Institute |
| Conditions |
Intradialytic Hypotension |
| Enrollment |
26 participants |
| Start Date |
2023-12-11 |
| Primary Completion |
2026-07-01 (estimated) |
| Study Completion |
2026-11-01 (estimated) |
| Updated on ClinicalTrials.gov |
2026-04-15 |