NCT00214279

MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
DRUG	Corticosteroid withdrawal	prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

Timeline

• Start date: 2002-05-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-09-21
• Last updated: 2012-06-26

Locations

1 site across 1 country: United States