Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286624
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2006-02-02
Brief Title:
Anti-Thymocyte Globulin Cyclosporine and RAD in Islet Transplantation
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A One-Year Single-Center Prospective Open-Label Study of the Safety Tolerability and Preliminary Efficacy of Anti-Thymocyte Globulin Cyclosporine and RAD in Type 1 Diabetic Islet Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NITA
Brief Summary:
This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet transplants in type 1 diabetic patients with hypoglycemia unawareness 6 subjects were transplanted under this protocol using anti-thymocyte globulin induction immunosuppression and everolimus with cyclosporine maintenance immunosuppression
Detailed Description:
This is a Phase III study designed to assess the safety and efficacy of sequential islet allotransplantation for the reestablishment of stable glycemic control in type 1 diabetic recipients A total of 6 patients with type 1 diabetes have received up to three transplants of islets from different donor pancreases
Potential candidates for islet allotransplantation included patients age 18 and older with type 1 diabetes Induction immunotherapy for the first transplant consisted of anti-thymocyte globulin basiliximab was used for any subsequent transplants Peritransplant anti-inflammatory treatment with etanercept was given for each islet transplant Maintenance immunosuppression is with cyclosporine and RAD It is felt that those patients in whom metabolic labilityinstability reduced awareness of hypoglycemia poor glycemic control and progressive secondary complications persist despite continued and intensive efforts made in close cooperation with their diabetes care team are particularly likely to have a favorable benefitrisk ratio
Adverse events irrespective of their presumed relationship to the transplantation of allogeneic islets andor protocol-regulated treatment products concomitant therapy are being monitored and recorded throughout the first year after the final islet transplant
The proportion of single and sequential donor islet allograft recipients with full insulin independence and HbA1c 7 and partial insulin dependence basal or arginine-stimulated C-peptide levels of greater or equal to 05 ngmL and HbA1c 7 islet graft function at one year after the final islet transplant will be assessed The impact of islet transplantation on quality of life will also be assessed
The predictive value for posttransplant insulin independence of factors such as insulin resistance before and at intervals after pancreatectomy cellular composition of the transplant number of beta cells transplanted and viability and insulin secretory response of isolated islets are being assessed
Potential candidates for islet allotransplantation included patients age 18 and older with type 1 diabetes Induction immunotherapy for the first transplant consisted of anti-thymocyte globulin basiliximab was used for any subsequent transplants Peritransplant anti-inflammatory treatment with etanercept was given for each islet transplant Maintenance immunosuppression is with cyclosporine and RAD It is felt that those patients in whom metabolic labilityinstability reduced awareness of hypoglycemia poor glycemic control and progressive secondary complications persist despite continued and intensive efforts made in close cooperation with their diabetes care team are particularly likely to have a favorable benefitrisk ratio
Adverse events irrespective of their presumed relationship to the transplantation of allogeneic islets andor protocol-regulated treatment products concomitant therapy are being monitored and recorded throughout the first year after the final islet transplant
The proportion of single and sequential donor islet allograft recipients with full insulin independence and HbA1c 7 and partial insulin dependence basal or arginine-stimulated C-peptide levels of greater or equal to 05 ngmL and HbA1c 7 islet graft function at one year after the final islet transplant will be assessed The impact of islet transplantation on quality of life will also be assessed
The predictive value for posttransplant insulin independence of factors such as insulin resistance before and at intervals after pancreatectomy cellular composition of the transplant number of beta cells transplanted and viability and insulin secretory response of isolated islets are being assessed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None