Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Stopped early · Phase 4
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00177138
- Run by
- University of Minnesota
- People needed
- 9
- Starts
- 2004-07-01
- Expected to finish
- 2006-11-01
- Last updated by the study team
- 2013-02-07
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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. -
Where it is running
- University of Minnesota-Fairview — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.