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Also known as rabbit anti-thymocyte globulin, Thymoglobulin, rATG
Single-dose rabbit Anti-thymocyte Globulin induction · 6 trials · 19 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
A positive test result will indicate immune reconstitution, while a negative test results will indicate lack of immune reconstitution. Participants not done (ND) will be counted with the negative (Neg).
| 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 |
| ATG 1.7 mg/kg, TBI, transplant | EXPERIMENTAL | (Rabbit-ATG;Thymoglobulin,Genzyme) ATG 5.1 mg/kg in three divided doses (1.7 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive lower dose anti-thymocyte globulin IV on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30. |
| ATG 2.5 mg/kg/d, TBI, transplant | EXPERIMENTAL | (Rabbit-ATG;Thymoglobulin,Genzyme) ATG 7.5 mg/kg in three divided doses (2.5 mg/kg/d) given over three days (day -9 to -7) followed by 450 cGy TBI and tacrolimus plus MMF GVHD prophylaxis. Patients receive higher dose anti-thymocyte globulin intravenously (IV) on days -9 to -7. Patients undergo total-body radiation (TBI) twice daily (BID) on day -1 and once daily (QD) on day 0. Patients then undergo peripheral blood stem cells or bone marrow transplant on day 0. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: patients receive tacrolimus orally (PO) on days -2 to 90-120 with taper for 2 months, and mycophenolate mofetil (MMF) PO BID on days 0-30. |
| 1 | EXPERIMENTAL | Standard (tacrolimus based standard therapy without induction) |
| 2 Standard of Care | ACTIVE_COMPARATOR | Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy |
| 1 Control | ACTIVE_COMPARATOR | Simulect (basiliximab) |
| 2 | EXPERIMENTAL | Thymoglobulin (anti-thymocyte globulin (rabbit)) |
| Dose Level 1 | EXPERIMENTAL | Thymoglobulin 2.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Dose Level 2 | EXPERIMENTAL | Thymoglobulin 3.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Dose Level 3 | EXPERIMENTAL | Thymoglobulin 4.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| 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. |
| Thymoglobulin | BIOLOGICAL | Patients eligible for participation in this study will be randomized between receiving rabbit ATG for 3 days. Thymoglobulin will be administered according to VCU BMT standard of care starting day -9 and continued daily through day -7. |
| Total-Body Irradiation | RADIATION | Undergo TBI |
| Allogeneic PBSCT or BMT | PROCEDURE | Undergo allogeneic PBSCT or BMT |
| Tacrolimus | DRUG | Given PO |
| Mycophenolate Mofetil | DRUG | Given PO |
| Corticosteroid | DRUG | For a minimum of 3 months |
| Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] | DRUG | - |
| Simulect (basliximab) | DRUG | 20 mg per day on 2 days |
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...
Single-dose rabbit Anti-thymocyte Globulin induction is an investigational therapeutic approach being studied in end-stage renal disease, specifically in kidney transplantation. It involves giving a single dose of rabbit anti-thymocyte globulin as induction therapy, rather than multiple doses, and was evaluated in a Phase 2 safety trial.
It is being studied as induction therapy in patients with end-stage renal disease who are undergoing kidney transplantation. The Phase 2 trial enrolled 99 patients to assess the safety of a single dose compared with multiple doses of Thymoglobulin induction in kidney transplantation.
Sanofi, which trades under the ticker SNY, is the developer associated with rabbit anti-thymocyte globulin, marketed as Thymoglobulin. The single-dose induction regimen was evaluated in a company-sponsored Phase 2 trial in kidney transplant recipients with end-stage renal disease.
Single-dose rabbit Anti-thymocyte Globulin induction is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational for this single-dose induction use and is not described as approved for it.
The regimen was studied in NCT00906204, titled Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation. This completed Phase 2 trial enrolled 99 patients in the United States, was randomized, double-blind, and active-controlled, and included adults aged 18 years and older.
Yes. Single-dose rabbit Anti-thymocyte Globulin induction refers to the same agent as rabbit anti-thymocyte globulin, given as a single induction dose. The alternative name reflects the dosing strategy studied in the Phase 2 kidney transplantation trial rather than a different product.