Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063817
Status:
COMPLETED
Last Update Posted:
2017-12-27
First Post:
2003-07-07
Brief Title:
Reducing the Risk of Transplant Rejection Simultaneous Kidney and Bone Marrow Transplant
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Renal Allograft Tolerance Through Mixed Chimerism ITN010ST
Status:
COMPLETED
Status Verified Date:
2017-12
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:
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same or nearly the same blood cell type as the transplant recipient An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the bodys immune system
Detailed Description:
Of the two currently available treatments for kidney failure long-term dialysis and kidney transplantation only kidney transplantation provides a potential cure After a kidney transplant the bodys immune system recognizes the kidney as foreign and tries to attack and destroy it in a process called rejection To avoid rejection participants must take medications called immunosuppressants or anti-rejection drugs It is believed that by transplanting bone marrow at the same time as a solid organ such as a kidney a state of mixed chimerism a mixing of the donor and recipients immune system can be achieved Mixed chimerism may prevent rejection without the need for anti-rejection drugs
Participants in this study will receive a simultaneous bone marrow and kidney transplant from the same living related donor in an attempt to establish mixed chimerism Prior to transplantation participants will undergo a conditioning regimen involving cyclophosphamide chemotherapy radiation to the thymus gland and four immunosuppressive medications cyclosporine A a man-made antibody known as rituximab to suppress B cells a short course of steroids and a T-cell depleting antibody known as MEDI-507 MEDI-507 is an investigational medication that has not been approved by the FDA The primary goal of the study is to investigate the safety of the conditioning regimen and its ability to promote mixed chimerism so that the transplanted kidney is not destroyed The study will also determine whether participants with mixed chimerism can eventually be safely removed from long-term immunosuppressive therapy following transplantation
Participants will be assessed before and after transplantation and will be followed 36 months
Participants in this study will receive a simultaneous bone marrow and kidney transplant from the same living related donor in an attempt to establish mixed chimerism Prior to transplantation participants will undergo a conditioning regimen involving cyclophosphamide chemotherapy radiation to the thymus gland and four immunosuppressive medications cyclosporine A a man-made antibody known as rituximab to suppress B cells a short course of steroids and a T-cell depleting antibody known as MEDI-507 MEDI-507 is an investigational medication that has not been approved by the FDA The primary goal of the study is to investigate the safety of the conditioning regimen and its ability to promote mixed chimerism so that the transplanted kidney is not destroyed The study will also determine whether participants with mixed chimerism can eventually be safely removed from long-term immunosuppressive therapy following transplantation
Participants will be assessed before and after transplantation and will be followed 36 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DAIT NKD03 | OTHER | Immune Tolerance Network | None |