Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346151
Status:
TERMINATED
Last Update Posted:
2017-04-21
First Post:
2006-06-27
Brief Title:
Belatacept to Prevent Organ Rejection in Kidney Transplant Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Safety and Efficacy of Belatacept Antithymocyte Globulin and Sirolimus in Recipients of Non-HLA-identical Living-donor Renal Transplants ITN023ST
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopping rule-acute rejection threshold-was met based on local biopsy results
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BESTT
Brief Summary:
Belatacept is an experimental medication shown in clinical trials to have immune system suppression properties in people who have had renal eg kidney transplants This study will determine whether a combination of anti-rejection drugs including belatacept can prevent the rejection of a first-time non-human leukocyte antigen HLA identical renal transplant and allow patients to be safely withdrawn from anti-rejection therapy one year post-transplant
Detailed Description:
Drugs that suppress the immune system have contributed to increased success of transplantation however to prevent organ rejection transplant recipients need to take immunosuppressive drugs for the rest of their lives These drugs make patients more susceptible to infection and certain kinds of cancer Belatacept is an experimental medication that specifically targets immune reactions against transplanted organs and has been shown to be effective in preventing kidney transplant rejection in previous clinical trials Both thymoglobulin an antibody and sirolimus an anti-rejection drug prevent rejection by lowering the response of the immune system to the transplanted organ This study will evaluate whether belatacept along with thymoglobulin and sirolimus is safe in kidney transplant patients The study will also evaluate this regimens potential to allow tapering and eventual discontinuation of all immunosuppressive drugs
This study will last up to 4 years At the time of transplant participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin sirolimus and belatacept Participants will receive infusions of thymoglobulin on days 1 through 4 and a combination of oral sirolimus daily and belatacept infusions at day 5 then weeks 2 4 8 and monthly for at least 2 years Dose reduction of belatacept will occur at 12 weeks post-transplant At Year 2 eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study Study visits will occur weekly for the first two months then monthly These visits will include belatacept treatment general medical assessments blood and urine collection and other assessments to determine overall health of the recipients immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants
IMPORTANT NOTICE The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell organ or tissue transplants outside of physician-directed controlled clinical studies Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances upon the recommendation and with the guidance of your health care provider
This study will last up to 4 years At the time of transplant participants will begin an immunosuppressive treatment regimen consisting of thymoglobulin sirolimus and belatacept Participants will receive infusions of thymoglobulin on days 1 through 4 and a combination of oral sirolimus daily and belatacept infusions at day 5 then weeks 2 4 8 and monthly for at least 2 years Dose reduction of belatacept will occur at 12 weeks post-transplant At Year 2 eligible participants may choose to begin drug withdrawal or continue study therapy through the end of the study Study visits will occur weekly for the first two months then monthly These visits will include belatacept treatment general medical assessments blood and urine collection and other assessments to determine overall health of the recipients immune system and kidney transplant and to better understand the way the immune system works in the acceptance or rejection of organ transplants
IMPORTANT NOTICE The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell organ or tissue transplants outside of physician-directed controlled clinical studies Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances upon the recommendation and with the guidance of your health care provider
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