MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant
recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and
MMF), while carefully monitoring their graft function. 25 subjects would serve as control
patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and
MMF). Immunologic status will be determined before and after IS withdrawal using a
delayed-type hypersensitivity (DTH) transfer test previously described in the original
submission. Both the steroid withdrawal subjects and the control subjects will undergo the
DTH testing throughout the 3 years of study participation.