Renal Transplantation
Conditions
Brief 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.
Interventions
DRUGCorticosteroid withdrawal
prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Allograft rejection | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function as determined by serum creatinine | measure after 36 months | — |
| Allograft Survival | 3 years | — |
| Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH) | Day 0 (pre-transplant) | Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study. |
Countries
United States
Outcome results
None listed