New hope for dialysis patients: drug aims to stop blood pressure crashes

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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