NCT05297786CompletedPhase 2
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 17 Mar 2022
- Start date
- 27 Jul 2022
- Primary completion date
- 26 Sept 2024
- Lead sponsor
- Vanderbilt University Medical Center
- Diseases
- Chronic kidney disease
- NCT number
- NCT05297786
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 28
- From 27 Jul 2022 to the primary completion date, 26 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated live donor kidney transplant
- Use of immunosuppressive drugs within one month before study enrollment
- History of acute infections disease within one month before study enrollment
Other illness
- History of myocardial infarction or cerebrovascular event within 3 months
- History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
- Advanced liver disease
- A history of poor adherence to hemodialysis or medical regimen
- Active connective tissue disease
Lab values
- Ejection fraction less than 30%
- Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions
Other
- Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
- Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
- Inability to provide consent
- Pregnancy
Who the study is looking for
- Subjects age 18 to 85 years
- On thrice-weekly hemodialysis for at least six months
- Clinically stable, adequately dialyzed (single-pool Kt/V \> 1.2), with polysulphone membrane for at least three consecutive months before the study
- Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
- Subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmHg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety.
- Hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions).
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.