drugset / Trial / NCT01653847

Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens

NCT01653847

RandomizedParallel-groupOpen-labelTreatment

Summary

The immune system is the body's defense against infection and other disease. After transplantation, the body sees the new organ as "foreign" and tries to destroy or "reject" it. Immunosuppressive medications help to prevent the immune system from attacking a transplanted organ. The primary purpose of this study is to investigate the impact of two maintenance immunosuppressive regimens. Subjects who enroll in this study will be randomly selected to have tacrolimus and everolimus (group 1) or tacrolimus and mycophenolate mofetil (group 2) as their immunosuppression medication. This study will enroll adult patients who are scheduled to receive a kidney transplant. The study is designed to understand the mechanisms of Everolimus in regards to kidney function in transplant recipients. The investigators hypothesis is that decreased exposure to Tacrolimus to the immune system will then translate in better renal allograft function.

Timeline

Start
2013-02
Primary completion
2020-05
Completion
2020-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Everolimus Small molecule 0.75 mg
Comparator Mycophenolate Mofetil Small molecule 1 g
Comparator Tacrolimus Small molecule