Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05834777 | Prevention of Intradialytic Hypotension by Inhibiting Bradykinin B2 Receptor | PHASE3 | RECRUITING | 26 | — | — | Dec 11, 2023 | Nov 1, 2026 | Apr 15, 2026 | 1 | United States |
Average systolic blood pressure
| Arm | Type | Description |
|---|---|---|
| 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) |
| Placebo | PLACEBO_COMPARATOR | 153 mL 0.9% saline bag IV at each dialysis treatment at each dialysis treatment for four weeks (12 hemodialysis sessions) |
| Name | Type | Description |
|---|---|---|
| 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 |
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 hemodial...