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Also known as rabbit anti-thymocyte globulin
Single-dose rabbit Anti-thymocyte Globulin induction · 1 trial · 2 indications
The composite endpoint components and definitions are: * Fever: Body temperature ≥ 38.5˚C. * Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors. * Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for \> 12 hours out of a 24 hour period. * Cardiac events: Myocardial Infarction, clinically significant dysrhythmia (atrial fibrillation, atrial flutter, ventricular fibrillation and ventricular tachycardia) * Delayed graft function (DGF): Requirement for dialysis within 7 days of transplantation
| Arm | Type | Description |
|---|---|---|
| Single-dose Thymoglobulin | EXPERIMENTAL | Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion |
| Divided-dose Thymoglobulin | ACTIVE_COMPARATOR | Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4 |
| Name | Type | Description |
|---|---|---|
| Single-dose rabbit Anti-thymocyte Globulin induction | BIOLOGICAL | 6 mg of rATG administered in a single dose on the day of kidney transplantation |
| Divided-dose rabbit Anti-thymocyte Globulin induction | BIOLOGICAL | 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation. |
Inclusion Criteria: * Subject capable of giving written informed consent, with end-stage kidney disease, who is a suitable candidate for primary kidney transplantation * Male or female subject who has reached legal age in the state where they reside and is at least 18 years of age * Deceased or liv...