NCT05834777 Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
| NCT ID | NCT05834777 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Intradialytic Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2023-12-11 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 26 participants in total. It began in 2023-12-11 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Jorge L Gamboa, MD/PhD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05834777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intradialytic Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05834777 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 26 participants.
Is NCT05834777 currently recruiting?
Yes, NCT05834777 is actively recruiting participants. Contact the research team at delia.woods@vumc.org for enrollment information.
Where is the NCT05834777 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05834777 clinical trial?
NCT05834777 is sponsored by Vanderbilt University Medical Center. The principal investigator is Jorge L Gamboa, MD/PhD at Vanderbilt University Medical Center. The trial plans to enroll 26 participants.