Status:
TERMINATED
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Bayer
Gruessner, Rainer, MD
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
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, gr...
Detailed Description
Secondary objectives of the study are: 1. Compare the side effects of the immunosuppressive medications between both groups. This will include anaphylactic reactions, GI side-effects, bone marrow sup...
Eligibility Criteria
Inclusion
- Previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant.
- Recipient age 18-60 years
- Donor age 10-59 years
- Females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study.
- Enteric or bladder drained pancreas transplant.
- \-
Exclusion
- Use of an investigational drug in the last 1-year.
- Positive T or B cell crossmatch.
- WBC\<3000 at enrollment
- Platelet count \<50,000 at enrollment
- History of malignancy (exclusive of minor skin cancers)
- Inability to give informed consent
- Systemic infections
- Major active or chronic infections, including documented HIV infection (by any licensed ELISA and confirmation by Western Blot).
- Serology negative for EBV pre-transplant.
- No other previous organ transplants other than pancreas and/or kidney. -
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00177138
Start Date
July 1 2004
End Date
November 1 2006
Last Update
February 7 2013
Active Locations (1)
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1
University of Minnesota-Fairview
Minneapolis, Minnesota, United States, 55414