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Prevention study for Intradialytic Hypotension
Official title Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
ClinicalTrials.gov ID: NCT05834777
What this study is testing
What is Icatibant?
Icatibant is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intradialytic hypotension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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
You likely can't join if
- 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.
See the full eligibility 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...
- Female people \< 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.