drugset / Trial / NCT02377193

Simulect Versus ATG in Sensitized Renal Transplant Patient

NCT02377193

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

EvaluationDrugModalityDoseRoute
Subject Basiliximab Monoclonal antibody 40 mg Intravenous
Comparator Thymoglobulin Protein / enzyme biologic 3 mg/kg Intravenous

Indications