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Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

ConditionIntradialytic Hypotension
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVanderbilt University Medical Center

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Icatibant

    Drug

    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).

  • Placebo

    Drug

    0.9% sodium chloride will be administered as the same rate as icatibant

Treatment groups

26 Participants
are divided into 2 treatment groups
Group A: IcatibantExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blood pressure during hemodialysis

Average systolic blood pressure

Time frame
0-8 weeks

Secondary outcomes

1

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

Time frame
0-8 week
2

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.

Time frame
0-8 weeks

Other outcomes

Sponsors and contacts

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Vanderbilt University Medical Center

Lead sponsor

Pharvaris Netherlands B.V.

Collaborator

Renal Research Institute

Collaborator

Source ClinicalTrials.gov
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