Preventing low blood pressure during hemodialysis using icatibant
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study
This study is testing if a medication called icatibant can help prevent low blood pressure during hemodialysis for patients, making their treatment more comfortable and improving their recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05834777 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of icatibant, a bradykinin B2 receptor inhibitor, in preventing intradialytic hypotension (IDH) in patients undergoing hemodialysis. The study will monitor heart rate and blood pressure during regular hemodialysis sessions to assess the drug's ability to maintain hemodynamic stability and alleviate symptoms associated with IDH, such as cramps and dizziness. Additionally, it will explore the impact of icatibant on improving patients' quality of life and reducing recovery time after dialysis. The trial will be conducted in an outpatient setting, ensuring that patients receive their usual dialysis treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with end-stage renal disease on hemodialysis who have experienced recurrent episodes of intradialytic hypotension.
Not a fit: Patients who do not experience recurrent intradialytic hypotension or those with unstable clinical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve blood pressure stability and overall quality of life for patients undergoing hemodialysis.
How similar studies have performed: While the approach of using icatibant for this purpose is novel, other studies have explored interventions for managing intradialytic hypotension with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 to ≤ 80 years of age * Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for at least 6 months, receiving 3 dialysis sessions per week and who are in a stable clinical condition per investigator's judgement * Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks based on medical record assessment * Pre-dialysis systolic blood pressure ≥ 110 and ≤ 170 mmHg assessed by two consecutive and averaged pre-HD blood pressure measurments * Patients adequately hemodialyzed with a Kt/V ≥ 1.2 * Patients whose treatment regimen remained unchanged within 14 days prior to dosing (diet, medication, dry weight, treatment time, dialysate composition and temperature, dialysis shift, blood flow, and dialysate flow, vascular access) * Female subjects \< 55 years of age to agree on effective contraception methods throughout the study period and who have a negative pregnancy test before initiating study activities * Body weight ≤ 150 kg Exclusion Criteria: * Patients who have been hospitalized during the last 4 weeks before enrolment, except vascular access related hospitalization * Patients with known clinically evident inflammatory or infectious disease per investigator's evaluation * Severe anemia with a hemoglobin (Hb) \< 8.0 g/dL at screening * Platelet count \< 50 x 109/L * Hepatic disease associated with ALT \> 3x ULN, or total bilirubin \>2x ULN with direct bilirubin \> 20% of the total bilirubin level * Known bleeding disorders e.g., von-Willebrand disease or Hemophilia A, B, C, etc. * Recent (\<3 months before screening) thromboembolic event, e.g., acute coronary syndrome, stroke, or venous thrombosis embolism (except dialysis access thrombosis) * Recent (\<3 months before screening) major surgery or scheduled major surgery during study participation * Scheduled living donor renal transplant during study participation * Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher * Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day * Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure * Patients with significant pre-dialysis overload as defined by \> 5kg above dry weight estimated by bioimpedance spectroscopy * Patient's life expectancy \< 6 months per investigator's judgement
Where this trial is running
Nashville, Tennessee
- Vanderbilt Fresenius — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Jorge L Gamboa, MD/PhD — Vanderbilt University Medical Center
- Study coordinator: Delia M Woods, BSN/MSL
- Email: delia.woods@vumc.org
- Phone: 615-327-7181
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.