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

University of Wisconsin, Madison32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Incidence of Allograft rejection

Time frame: 3 years

Secondary Outcomes

Renal function as determined by serum creatinine

Time frame: measure after 36 months

Allograft Survival

Time frame: 3 years

Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)

Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.

Time frame: Day 0 (pre-transplant)