Treatment for low blood pressure during hemodialysis in kidney disease patients
Prevention of Dialysis-Induced Hypotension by Inhibiting Plasma Kallikrein
This study is testing if a new medication can help people with end-stage kidney disease avoid low blood pressure during their hemodialysis sessions.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | lanadelumab |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05297786 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of lanadelumab, a medication that blocks plasma kallikrein, to prevent low blood pressure during hemodialysis in patients with end-stage kidney disease. The study will be a double-blind, placebo-controlled trial involving participants who experience significant drops in blood pressure during their dialysis sessions. By evaluating the effectiveness of lanadelumab compared to a placebo, the researchers aim to determine if this treatment can improve patient outcomes related to dialysis-induced hypotension.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 who have been on hemodialysis for at least six months and experience significant blood pressure drops during treatment.
Not a fit: Patients who have severe hypertension or require pharmacological interventions for hypotension during dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of hypotension during hemodialysis, improving the quality of life for patients with end-stage kidney disease.
How similar studies have performed: Preliminary results from earlier trials suggest that similar approaches may be effective, but this specific intervention is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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 * Ejection fraction less than 30% * Anticipated live donor kidney transplant * A history of poor adherence to hemodialysis or medical regimen * Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions * Use of immunosuppressive drugs within one month before study enrollment * Active connective tissue disease * History of acute infections disease within one month before study enrollment * Inability to provide consent * Pregnancy
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Jorge L Gamboa, M.D. Ph.D.
- Email: jorge.gamboa@vumc.org
- Phone: 6153434176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.