drugset / Trial / NCT02377193
Simulect Versus ATG in Sensitized Renal Transplant Patient
Phase 4
Completed
60 enrolled
University Hospital, Toulouse
Neovii Biotech · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Induction therapy by either T-cell depleting polyclonal antibodies such as anti-thymocyte globulins (ATG) or non-depleting anti-interleukine 2 receptor monoclonal antibodies (anti-CD25 moAb: basiliximab or daclizumab) are used to prevent acute rejection, especially in highly sensitized patients. Both induction therapy regimens have a different tolerance profile. Infections and haematological side-effects are more frequently reported in patients receiving ATG. The aim of the pilot study is to evaluate ATG and basiliximab induction therapy in de novo sensitized kidney-transplant patients (incompatible grafts rate ≥ 50%) without donor specific antibodies (DSAs) detected by Luminex.
Timeline
- Start
- 2013-09
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Basiliximab | Monoclonal antibody | 40 mg | Intravenous |
| Comparator | Thymoglobulin | Protein / enzyme biologic | 3 mg/kg | Intravenous |