Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001857
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Study Comparing the Safety of BG9588 Anti-CD40L Antibody Against Standard Treatment in Kidney Transplantation
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Multicenter Open-Label Study to Determine the Safety of BG9588 Anti-CD40L Antibody Therapy Compared to Standard Treatment in Renal Allograft Transplantation
Status:
COMPLETED
Status Verified Date:
1999-05
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:
None
Brief Summary:
The most common problem following a kidney transplant is the development of acute or chronic rejection Rejection is the immunologic reaction in which the body refuses to accept the transplanted organ The bodys immune system will make destructive antibodies that will attempt to attack the transplanted organ
In order to prevent organ rejection all patients receiving an allograft a graft transplanted between genetically non-identical individuals of the same species must take anti-rejection therapy These medications function by lowering the bodys natural immune system Often these medications are associated with significant side effects ranging from infections to cancer
This study is designed to test whether the drug presently known as BG9588 Antova TM can reduce the incidence of organ rejection following kidney transplants in humans More specifically the study will attempt to assess the safety of BG9588 when given alone or when given in combination with other anti-rejection therapies Safety will be measured by the amount of acute or chronic rejections and immunological graft losses
Subjects for the study will be made up of non-human primates monkeys and humans Up to 5 subjects in each of the groups receiving kidney transplants will be placed on a 12 month course of BG9588 with or without additional anti-rejection drugs BG9588 will be given intravenously injected through a vein prior to the transplant and then in a decreased dose with a decreased frequency over the year Following the 12 months of therapy subjects may be eligible for additional monthly therapy
The long-term follow up will occur through 30 months after the last dose of BG9588 Subjects will undergo periodic tests and evaluations throughout the course of the study These tests will assess the bodys immune system and detect the presence of rejection
In order to prevent organ rejection all patients receiving an allograft a graft transplanted between genetically non-identical individuals of the same species must take anti-rejection therapy These medications function by lowering the bodys natural immune system Often these medications are associated with significant side effects ranging from infections to cancer
This study is designed to test whether the drug presently known as BG9588 Antova TM can reduce the incidence of organ rejection following kidney transplants in humans More specifically the study will attempt to assess the safety of BG9588 when given alone or when given in combination with other anti-rejection therapies Safety will be measured by the amount of acute or chronic rejections and immunological graft losses
Subjects for the study will be made up of non-human primates monkeys and humans Up to 5 subjects in each of the groups receiving kidney transplants will be placed on a 12 month course of BG9588 with or without additional anti-rejection drugs BG9588 will be given intravenously injected through a vein prior to the transplant and then in a decreased dose with a decreased frequency over the year Following the 12 months of therapy subjects may be eligible for additional monthly therapy
The long-term follow up will occur through 30 months after the last dose of BG9588 Subjects will undergo periodic tests and evaluations throughout the course of the study These tests will assess the bodys immune system and detect the presence of rejection
Detailed Description:
This protocol is an open label non-randomized study designed to test whether treatment with BG9588 a humanized monoclonal antibody specific for CD154 can induce a state of allograft tolerance following renal allotransplantation in humans This study is designed to primarily assess the safety and efficacy of BG9588 when given alone or in combination with steroids and mycophenolate to prevent renal allograft rejection without the use of calcineurin inhibitors or other chronic anti-rejection therapies Efficacy parameters will include the incidence of acute and chronic rejection episodes and immunological graft loss Additional evaluation will be performed to specifically assess the development of donor-specific immune hyporesponsiveness resulting from the use of BG9588
This study is based on extensive use of BG9588 in non-human primates and pilot evaluation in humans Up to five patients in each group receiving primary renal allografts will be treated with a 12-month course of BG9588 with or without steroids and mycophenolate to prevent allograft rejection The recruitment will be performed first in the group with steroids and mycophenolate Subjects will receive BG9588 at a dose of 70 mgkg based on ideal body weight at baseline via a continuous 60 minute IV infusion within 24 hours pre-operatively followed by a 30 mgkg dose via a continuous 30 minute IV infusion on the following days within 24 hours post-transplantation and on days 3 10 18 28 then monthly through 12 months post-transplantation The enrollment will be staggered such that early efficacy will be demonstrated in 5 patients prior to completing enrollment Following 12 months of therapy patients may be extended to receive additional monthly therapy
Long-term follow up will occur through 30 months after the last dose of BG9588 Mechanistic evaluations testing for allograft tolerance will be performed throughout the study including evaluations for allospecific T cell deletion allospecific T cell anergy and alloantibody production The donor population for this study will include both living donors and cadaveric donors This is being done to address the theoretical concern that ischemic reperfusion injury may negatively affect the efficacy of BG9588
This study is based on extensive use of BG9588 in non-human primates and pilot evaluation in humans Up to five patients in each group receiving primary renal allografts will be treated with a 12-month course of BG9588 with or without steroids and mycophenolate to prevent allograft rejection The recruitment will be performed first in the group with steroids and mycophenolate Subjects will receive BG9588 at a dose of 70 mgkg based on ideal body weight at baseline via a continuous 60 minute IV infusion within 24 hours pre-operatively followed by a 30 mgkg dose via a continuous 30 minute IV infusion on the following days within 24 hours post-transplantation and on days 3 10 18 28 then monthly through 12 months post-transplantation The enrollment will be staggered such that early efficacy will be demonstrated in 5 patients prior to completing enrollment Following 12 months of therapy patients may be extended to receive additional monthly therapy
Long-term follow up will occur through 30 months after the last dose of BG9588 Mechanistic evaluations testing for allograft tolerance will be performed throughout the study including evaluations for allospecific T cell deletion allospecific T cell anergy and alloantibody production The donor population for this study will include both living donors and cadaveric donors This is being done to address the theoretical concern that ischemic reperfusion injury may negatively affect the efficacy of BG9588
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 |
|---|---|---|---|
| 99-DK-0109 | None | None | None |