drugset / Trial / NCT02083991

Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation

NCT02083991

Phase 4 Completed 224 enrolled Vastra Gotaland Region
RandomizedParallel-groupOpen-labelTreatment

Summary

Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies. The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.

Timeline

Start
2013-01
Primary completion
2017-01
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Basiliximab Monoclonal antibody 20 mg Intravenous
Subject Prednisolone Other / unclassified 5 mg Intravenous
Subject Thymoglobulin Protein / enzyme biologic 2.5 mg/kg Intravenous

Indications