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

Completed · Not applicable

Conditions studied: Renal Transplantation

In brief

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.

Key facts

Study ID

NCT00214279

Run by

University of Wisconsin, Madison

People needed

32

Starts

2002-05-01

Expected to finish

2007-11-01

Last updated by the study team

2012-06-26

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient who have received a kidney transplant during the "MMF era"
• Patients who have stable graft function indicated by a serum creatinine of < 1.8 mg/dl, or a calculated creatinine clearance of > 50 ml/minute

You may not qualify if…

• Patients who have had > 1 rejection episode,
• Patients who have had a rejection episode within the past year;
• Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE

Where it is running

• Unversity of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.