Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062712
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-06-11
Brief Title:
Evaluating the Use of Thymoglobulin Sirolimus and Donor Bone Marrow With Kidney Transplantation Patients
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Induction of Donor Specific Immunologic Hyporesponsiveness With Thymoglobulin Sirolimus and Donor Bone Marrow Infusion
Status:
COMPLETED
Status Verified Date:
2007-03-22
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:
Patients with renal failure need chronic dialysis or a kidney transplant to survive Most kidney transplant patients must take medicines indefinitely to prevent their immune systems from rejecting the kidney Long-term exposure to these anti-rejection medicines can damage the transplanted kidney
The purpose of this study is to determine whether giving patients cells from the donors bone marrow will reduce or eliminate the need for long-term use of these anti-rejection drugs In addition to the donors bone marrow cells patients will receive the drugs thymoglobulin and sirolimus
A total of 20 patients will participate in this five-year study
The purpose of this study is to determine whether giving patients cells from the donors bone marrow will reduce or eliminate the need for long-term use of these anti-rejection drugs In addition to the donors bone marrow cells patients will receive the drugs thymoglobulin and sirolimus
A total of 20 patients will participate in this five-year study
Detailed Description:
This protocol will evaluate the combination of Thymoglobulin Sangstat sirolimus and donor bone marrow infusion for its ability to induce a state of donor specific hematopoietic chimerism and immune hyporesponsiveness within the context of renal transplantation Thymoglobulin Sangstat a FDA-approved polyclonal rabbit-IgG antithymocyte preparation will be given for up to ten days at the time of transplantation to effect lymphocyte depletion This will be combined with sirolimus rapamycin Wyeth-Ayerst an oral immunosuppressant agent recently approved by the FDA Sirolimus allows for antigen specific T cell activation but prevents T cell clonal expansion by interrupting IL-2 receptor beta-chain signal transduction Donor bone marrow will be administered seven days following transplant Patients demonstrating six months of rejection free graft survival will have their sirolimus withdrawn over three months beginning at the sixth month anniversary of the transplant
Twenty people will be evaluated in this pilot protocol Approximately ten will receive living donor kidney allografts and the remaining patients will receive cadaveric kidney allografts Patients will be treated with Thymoglobulin beginning prior to graft implantation and continuing for approximately ten days Glucocorticosteroids will be given during the first Thymoglobulin treatment to limit monocyte activation and prevent the cytokine release syndrome associated with the initial administration of this antibody preparation Patients will be given sirolimus orally beginning the day after transplantation and continuously thereafter Donor bone marrow will be administered seven days following transplantation Patients will then be monitored for evidence of allograft rejection using standard functional parameters and protocol allograft biopsies In addition patients will be followed for specific desired effects including a transient state of donor hematopoietic mixed microchimerism and allospecific AICD Both of these are expected to promote the development of allospecific graft tolerance This will be accomplished by assaying peripheral blood and allograft biopsies for apoptosis and the peripheral blood for evidence of alloreactive T cell clone depletion and donor chimerism
Twenty people will be evaluated in this pilot protocol Approximately ten will receive living donor kidney allografts and the remaining patients will receive cadaveric kidney allografts Patients will be treated with Thymoglobulin beginning prior to graft implantation and continuing for approximately ten days Glucocorticosteroids will be given during the first Thymoglobulin treatment to limit monocyte activation and prevent the cytokine release syndrome associated with the initial administration of this antibody preparation Patients will be given sirolimus orally beginning the day after transplantation and continuously thereafter Donor bone marrow will be administered seven days following transplantation Patients will then be monitored for evidence of allograft rejection using standard functional parameters and protocol allograft biopsies In addition patients will be followed for specific desired effects including a transient state of donor hematopoietic mixed microchimerism and allospecific AICD Both of these are expected to promote the development of allospecific graft tolerance This will be accomplished by assaying peripheral blood and allograft biopsies for apoptosis and the peripheral blood for evidence of alloreactive T cell clone depletion and donor chimerism
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 |
|---|---|---|---|
| 03-DK-0204 | None | None | None |