Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor

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 astable clinical condition per investigator's judgement

• Patients on hemodialysis with at least 6 IDH episodes during the last 8 weeks basedon medical record assessment

• Pre-dialysis systolic blood pressure ≥ 110 and ≤ 170 mmHg assessed by twoconsecutive 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 andtemperature, dialysis shift, blood flow, and dialysate flow, vascular access)

• Female subjects < 55 years of age to agree on effective contraception methodsthroughout the study period and who have a negative pregnancy test before initiatingstudy activities

• Body weight ≤ 150 kg

Exclusion Criteria:

• Patients who have been hospitalized during the last 4 weeks before enrolment, exceptvascular access related hospitalization

• Patients with known clinically evident inflammatory or infectious disease perinvestigator'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 directbilirubin > 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 coronarysyndrome, stroke, or venous thrombosis embolism (except dialysis access thrombosis)

• Recent (<3 months before screening) major surgery or scheduled major surgery duringstudy 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 anticoagulationduring the hemodialysis procedure

• Patients with significant pre-dialysis overload as defined by > 5kg above dry weightestimated by bioimpedance spectroscopy

• Patient's life expectancy < 6 months per investigator's judgement