Intradialytic HypotensionPhase 3NCT05834777
Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor
A Phase 3 study testing Icatibant in people with Intradialytic Hypotension, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intradialytic Hypotension
- What is being tested?
- Icatibant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2023to 1 Nov 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor A Randomized, Double-blind, Placebo-controlled, Cross Over Explorative Study
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.
Read the detailed description
Aim 1 is to test the hypothesis that in patients prone to IDH, blockade of bradykinin B2 receptor with icatibant prevents the drop of blood pressure and maintains hemodynamic stability. For this purpose, heart rate and blood pressure during hemodialysis are monitored. Importantly, the study will be conducted in an outpatient clinic, using the patients' usual hemodialysis dose and settings as for a regular hemodialysis session.
Aim 2 is to test the hypothesis that in patients prone to IDH, inhibition of the plasma kallikrein system with icatibant prevents symptoms associated with IDH such as cramps, dizziness, and nausea, and improves the quality of life (QoL) and recovery time after hemodialysis. Hemodialysis is associated with many complications, including IDH, that negatively affect the QoL of patients and their families. Any intervention that prevents the occurrence of IDH will result in a faster recovery from hemodialysis. The present study will evaluate the impact of icatibant on preventing symptoms associated with IDH and reducing recovery time after hemodialysis.
- Conditions
- Intradialytic Hypotension
- Being tested
- Icatibant, Placebo
- Keywords
- Hemodialysis, Intradialytic hypotension, Bradykinin, Kallikrein-Kinin System, Icatibant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcatibantDrug
Icatibant will be administered with an infusion rate of 100µg/kg/h for 15 minutes before their hemodialysis session (pre-infusion) and 50µg/kg/h during their routine hemodialysis session (maintenance infusion).
PlaceboDrug
0.9% sodium chloride will be administered as the same rate as icatibant
| Study group | Role | What they receive |
|---|---|---|
| Icatibant | Experimental | 153 mL 0.9% saline bag containing 30 mg icatibant acetate (10 mg/ml) IV at each dialysis treatment for four weeks (12 hemodialysis sessions) Receives: Drug: Icatibant |
| Placebo | Placebo comparator | 153 mL 0.9% saline bag IV at each dialysis treatment at each dialysis treatment for four weeks (12 hemodialysis sessions) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure during hemodialysis
Average systolic blood pressure
Measured: 0-8 weeks
Secondary outcomes (2)
Hypotension events
We will record the number of hypotensive events during hemodialysis. We expect a decrease of event in the treatment arm compared to placebo
Measured: 0-8 week
Symptomatology associated with hypotension
At the end of each hemodialysis session in the cross-over main study, the presence of any symptoms associated with hypotension using a standardized questionnaire will be assessed. This questionnaire will include symptoms such as cramps, dizziness, nausea and fatigue rating, and will be scored according to the severity from 0 to 4 (none to severe) for the first listed symptoms, and according to the SONG-HD Fatigue scoring for the last listed symptom, respectively.
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start11 Dec 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, cross-over study, with a pharmocokinetics evaluation phase. Study duration for main cross-over study: Approximately 60 days including screening evaluation activities.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pharvaris Netherlands B.V., Renal Research Institute
- Responsible party
- Principal investigator, Jorge Gamboa, Vanderbilt University Medical Center
- Investigators
- Jorge L Gamboa, MD/PhD, Principal investigator, Vanderbilt University Medical CenterPeter Kotanko, MD, FASN, Principal investigator, Renal Research InstituteTalat A Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834777
- Sponsor's protocol ID
- 222301
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No