Efficacy of Islet After Kidney Transplantation: Age 18 to 68 Years

Study Name:  Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients: Efficacy of Islet After Kidney Transplantation (CIT-06)

Study Sponsors:  National Institute of Allergy and Infectious Diseases (NIAID); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Principal Investigator:  Andrew Posselt, MD, PhD

Who can sign up for this study?  For basic inclusion and exclusion criteria, access this link:  http://clinicaltrials.gov/ct2/show/NCT00468117

What is this study about?  Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control.  The purpose of this study is to assess the benefit of islet transplantation in type 1 diabetic (T1D) kidney transplant recipients.

What will happen in this study?  Up to three separate islet transplants will occur and a regimen of immunosuppressive medications consisting of antithymocyte globulin (ATG) and etanercept throughout study.  Participants will begin receiving ATG 2 days prior to the initial islet transplant and will continue to receive ATG until Day 2 post-transplant.  Daclizumab or Basiliximab will be used for subsequent transplants.  Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.

How long will this study last?  There will be approximately 15 study visits.  A physical exam, review of adverse events, and blood collection will occur at most visits.  A chest x-ray, abdominal ultrasound, electrocardiogram, quality of life questionnaire, and urine collection will occur at some visits.  Participants will also test their own blood glucose levels throughout the study.  A 36-month follow-up period will take place after the participant's last transplant, consisting of 8 additional visits.

For more information:  Joan McElroy, RN; 415-353-8893; islettransplant@ucsfmedctr.org