Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
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|ClinicalTrials.gov Identifier: NCT00177138|
Recruitment Status : Terminated (The clinical use of Campath for transplant patients was temporarily suspended.)
First Posted : September 15, 2005
Last Update Posted : February 7, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: Tacrolimus Drug: Alemtuzumab||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation|
|Study Start Date :||July 2004|
|Actual 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177138
|United States, Minnesota|
|University of Minnesota-Fairview|
|Minneapolis, Minnesota, United States, 55414|
|Principal Investigator:||Rainer W Gruessner, M.D.||University of Minnesota|