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NCT05834777 · ClinicalTrials.gov registry record · Phase 3
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
A Phase 3 study of Intradialytic Hypotension, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05834777: Recruiting Phase 3 study of Intradialytic Hypotension, sponsored by Vanderbilt University Medical Center.
NCT05834777 is a Phase 3 study of Intradialytic Hypotension that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 26 participants, below the 98-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05834777, a Phase 3 study of Intradialytic Hypotension, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Average systolic blood pressure
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Icatibant
Study Locations (1)
Tennessee
- Vanderbilt Fresenius - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2023-12-11 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 3 |
What NCT05834777 shows while recruiting
NCT05834777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 98-participant average among 3 other Intradialytic Hypotension trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Intradialytic Hypotension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05834777 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05834777 about?
NCT05834777 is a clinical study titled "Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor". 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 hemodi...
What is the current status of trial NCT05834777?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2023-12-11. Estimated completion is 2026-04-01.
What conditions does trial NCT05834777 study?
This clinical trial studies the following conditions: Intradialytic Hypotension.
What interventions are being tested in trial NCT05834777?
The interventions under investigation include: Placebo (DRUG), Icatibant (DRUG).
Who is sponsoring clinical trial NCT05834777?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05834777 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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