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

NCT00468117 Phase 3 COMPLETED

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.

Details

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	COMPLETED
Enrolment	24
Start date	2007-01
Completion	2017-07-05

Conditions

• Type 1 Diabetes Mellitus

Interventions

• Islet transplantation
• Antithymocyte Globulin
• Daclizumab or Basiliximab
• Etanercept
• Allogenic human purified pancreatic islets

Primary outcomes

• Proportion of patients w/HbA1c </= to 6.5% and an absence of severe hypoglycemic events or a reduction in HbA1c of at least 1 point and an absence of severe hypoglycemic events — At 1 year after first islet infusion

Countries

United States, Canada