Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
This is a single center, prospective, open-label, randomized trial at the University of Minnesota Medical Center,Fairview.
Primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a Campath/MMF-based (Group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and MMF (Group 2).
This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation|
- Time-to-event analysis will be used to analyze categorical end points that include graft failure, patient survival, biopsy documented rejection episode and non-compliance. [ Time Frame: 2 years ]
- The continuous outcome variable, weekly or bi-weekly serum creatinine levels, will be analyzed using a two-way repeated-measures analysis of variance. [ Time Frame: 2 years ]
|Study Start Date:||July 2004|
|Study Completion Date:||November 2006|
Active Comparator: Group 2
Starting POD #1 0.06 mg/kg/day in 2 divided doses;
Experimental: Group 1
30 mg IV intra-op and POD #12; then 30 mg IV >monthly for 1 year (only if ALC>200 mm, up to a total of 10 doses in year)
Secondary objectives of the study are:
- Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile.
- Compare the incidence of infections between both groups.
Comparison parameters are:
- Pancreas and kidney graft failure
- Patient death
- Clinical and biopsy documented rejection episodes
- Patient dropout (non-compliance with the study protocol)
- Kidney function as assessed by creatinine clearance or biopsy
- Need to change immunosuppression regimen
- Quality-adjusted Life Years
|United States, Minnesota|
|University of Minnesota-Fairview|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Rainer W Gruessner, M.D.||University of Minnesota - Clinical and Translational Science Institute|