drugset / Trial / NCT01095172

RituxiMab INDuction in Renal Transplantation

NCT01095172

RandomizedParallel-groupOpen-labelTreatment

Summary

Hypothesis: * That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival. Aim: * To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration. Objectives: * To assess whether B cell depletion affects graft function, acute rejection and complication rates * To assess whether the T cell response to allotransplantation is impaired by B cell depletion.

Timeline

Start
2010-11
Primary completion
2020-10
Completion
2022-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisolone Other / unclassified
Subject Rituximab Monoclonal antibody 375 mg/m2
Background Hydrocortisone Other / unclassified 100 mg
Background Mycophenolate Mofetil Small molecule 2 g
Background Tacrolimus Small molecule

Indications

No indication recorded.