Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434850
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2007-02-09
Brief Title:
Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes CIT-03
Status:
COMPLETED
Status Verified Date:
2016-02
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:
None
Brief Summary:
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 safety and efficacy of deoxyspergualin DSG an immunosuppressant drug on post-transplant islet function in people with type 1 diabetes who have not responded to intensive insulin therapy
Detailed Description:
Type 1 diabetes also known as insulin-dependent diabetes is a chronic disease in which the pancreas produces insufficient insulin to properly regulate blood sugar levels Hypoglycemia low blood sugar and hyperglycemia high blood sugar can lead to significant complications in people with type 1 diabetes Intensive insulin therapy has been shown to reduce the risk of chronic complications in people who achieve near normalization of glycemia However this therapy is labor intensive difficult to implement and associated with an increased frequency of severe hypoglycemia Transplantation of islets from a healthy pancreas has been successful in restoring normal blood sugar levels and has led to initial insulin independence in people with type 1 diabetes Rejection of these islets by the recipients immune system however makes the treatment ineffective within a couple of years Immunosuppressant drugs may be an effective way to maintain islet function post-transplant The purpose of this study is to assess the safety and efficacy of an immunosuppressive regimen that includes DSG on post-transplant islet function in people with type 1 diabetes who have not responded to intensive insulin therapy The study will also seek to improve the understanding of determinants of success and failure of islet transplants for type 1 diabetes
Following screening procedures and 2 days prior to islet transplant participants will be randomly assigned to either this Phase 2 trial or a multicenter Phase 3 trial Participants in this study will receive up to three separate islet transplants They will begin receiving antithymocyte globulin ATG and sirolimus 2 days prior to the first islet transplant ATG will continue to be given until Day 2 post-transplant Participants will continue taking sirolimus for the duration of the study On the day of transplant participants will receive DSG and etanercept in addition to ATG and sirolimus The DSG infusion will be administered over 3 hours and will immediately precede the islet transplant Participants will continue receiving daily 3-hour infusions of DSG through Day 6 post-transplant Etanercept will also be administered on Days 3 7 and 10 post-transplant Tacrolimus will be administered on Day 1 post-transplant and continued throughout the study
Transplantations will involve an inpatient hospital stay and infusion of islets into a branch of the portal vein Participants who do not achieve or maintain insulin independence by Day 75 post-transplant will be considered for a second islet transplant Participants who remain dependent on insulin for longer than 1 month after the second transplant and who show partial graft function will be considered for a third transplant Daclizumab or basiliximab will be used in place of ATG for the second and third transplants if they are necessary Participants who do not meet the criteria for a subsequent transplant and do not have a functioning graft will enter a reduced follow-up period
There will be up to 21 study visits following each transplant A physical exam review of adverse events blood collection urine tests and measures of immunosuppression levels will occur at most visits An abdominal ultrasound and glomerular filtration rate testing will occur at some study visits Participants will also self-test their glucose levels at least five times per day throughout the study A 12-month follow-up period will take place after the participants last transplant
Following screening procedures and 2 days prior to islet transplant participants will be randomly assigned to either this Phase 2 trial or a multicenter Phase 3 trial Participants in this study will receive up to three separate islet transplants They will begin receiving antithymocyte globulin ATG and sirolimus 2 days prior to the first islet transplant ATG will continue to be given until Day 2 post-transplant Participants will continue taking sirolimus for the duration of the study On the day of transplant participants will receive DSG and etanercept in addition to ATG and sirolimus The DSG infusion will be administered over 3 hours and will immediately precede the islet transplant Participants will continue receiving daily 3-hour infusions of DSG through Day 6 post-transplant Etanercept will also be administered on Days 3 7 and 10 post-transplant Tacrolimus will be administered on Day 1 post-transplant and continued throughout the study
Transplantations will involve an inpatient hospital stay and infusion of islets into a branch of the portal vein Participants who do not achieve or maintain insulin independence by Day 75 post-transplant will be considered for a second islet transplant Participants who remain dependent on insulin for longer than 1 month after the second transplant and who show partial graft function will be considered for a third transplant Daclizumab or basiliximab will be used in place of ATG for the second and third transplants if they are necessary Participants who do not meet the criteria for a subsequent transplant and do not have a functioning graft will enter a reduced follow-up period
There will be up to 21 study visits following each transplant A physical exam review of adverse events blood collection urine tests and measures of immunosuppression levels will occur at most visits An abdominal ultrasound and glomerular filtration rate testing will occur at some study visits Participants will also self-test their glucose levels at least five times per day throughout the study A 12-month follow-up period will take place after the participants last transplant
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