Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients: Efficacy of Islet After Kidney Transplantation (CIT-06/08)
Study Design: Clinical Trial
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1
Duration: 2008 – 2017
# Recruitment Centers: 10
Treatment: Islet Transplantation
Available Genotype Data: No
Image Summary: No
Transplant Type: Kidney Transplant
Does it have dialysis patients: No
Access to samples for Islet Transplantation in Type 1 Diabetic Kidney Allograft Recipients: Efficacy of Islet After Kidney Transplantation (CIT-06/08) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT00468117
The CIT consortium conducted a total of 9 studies across North America (CIT02 through CIT08) and the Nordic region (CIT01). CIT08 was a long-term follow-up study for interested participants at the North American sites. The target population is individuals with type 1 diabetes, normal kidney function, and intractable hypoglycemia. All studies treated participants with up to 3 separate infusions of islets. Unlike the other studies, subjects in CIT06 had previously received a kidney transplant and were receiving maintenance immunosuppression. CIT06 was a single arm Phase 3 license-supporting study. At the time of islet transplant, subjects in CIT06 received induction therapy in an open-label fashion with rabbit anti-thymocyte globulin (ATG, 5 doses; daclizumab or basiliximab instead of ATG for the 2nd and 3rd transplants, if applicable) and etanercept. Subjects remained on their calcineurin-based maintenance immunosuppression regimen already in place for their renal allograft.
The study aimed to determine the safety and efficacy of islet transplantation in type 1 diabetes patients who received a kidney transplant.
The primary outcome measure was the proportion of participants with an absence of severe hypoglycemic events and either a reduction in HbAc1 of at least 1 point or HbAc1 of at most 6.5%, assessed at 1 year after the first islet transfusion. Secondary outcome measures included reduction in insulin requirements, mean amplitude of glycemic excursions, renal and cardiovascular impact, and quality of life.
Individuals who met the following criteria were eligible for enrollment:
- Clinical history compatible with type 1 diabetes with onset at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28
- Absent stimulated C-peptide (less than 0.3 ng/mL) 60 and 90 minutes post-mixed-meal tolerance test
- Received kidney transplant for ESRD and are taking appropriate calcineurin inhibitor (CNI)-based maintenance immunosuppressive therapy
- Stable renal function (defined as creatinine of no more than one-third greater than the average creatinine determination performed in the 3 previous months prior to islet transplantation)
- Intensive diabetes management followed by reduced awareness of hypoglycemia or HbAc1 ≥ 7.5%.
Exclusion criteria are documented in the study protocol.
The study has concluded.