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NCT05297786 · ClinicalTrials.gov registry record · Phase 2
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
A Phase 2 study of Hemodialysis Complication and Hypotension of Hemodialysis, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05297786 is a Phase 2 study of Hemodialysis Complication and Hypotension of Hemodialysis that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 28 participants, below the 111-participant average among 3 other Hemodialysis Complication trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05297786, a Phase 2 study of Hemodialysis Complication and Hypotension of Hemodialysis, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot clinical trial showed that bradykinin B2 receptor blockade with icatibant prevents excessive blood pressure during hemodialysis. Thus, in this study, we will test the overarching hypothesis that blockade plasma kallikrein with lanadelumab would ameliorate the reduction of blood pressure during hemodialysis in patients who are prone to DIH. For this purpose, we will conduct a parallel arm, double-blind placebo-controlled trial, using lanadelumab to evaluate the occurrence of
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lanadelumab Injection [Takhzyro]
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05297786
The ClinicalTrials.gov registry entry for NCT05297786 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 111-participant average among 3 other Hemodialysis Complication trials with a reported enrollment target (75% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Hemodialysis Complication appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05297786 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05297786 about?
NCT05297786 is a clinical study titled "Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease". Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradykinin in dialysis-induced hypotension (DIH) has not been evaluated. Preliminary results from a pilot c...
What is the current status of trial NCT05297786?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2022-07-27. Estimated completion is 2026-01-31.
What conditions does trial NCT05297786 study?
This clinical trial studies the following conditions: Hemodialysis Complication, Hypotension of Hemodialysis.
What interventions are being tested in trial NCT05297786?
The interventions under investigation include: Placebo (DRUG), Lanadelumab Injection [Takhzyro] (DRUG).
Who is sponsoring clinical trial NCT05297786?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05297786 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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