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; firstname.lastname@example.org