Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090194
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
2004-08-25
Brief Title:
Improving Transplant Options of Highly Sensitized Recipients Using IGIV-C 10
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of Immune Globulin Intravenous Human 10 Manufactured by Chromatography Process IGIV-C 10 as an Agent to Reduce Anti-HLA Antibodies and Improve Transplantation Results in Cross Match Positive Living Donor Kidney Allograft Recipients
Status:
TERMINATED
Status Verified Date:
2017-01
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 purpose of this study is to determine if IGIV-C 10 will be effective in converting a donor-recipient crossmatch status from positive to negative The crossmatch test is used to determine if the donor tissue and recipient tissue are compatible The study will also evaluate if IGIV-C 10 will allow successful kidney transplantation in a patient who otherwise would not be able to receive a transplant Three dose levels of IGIV-C 10 will be evaluated to determine what dose level is most effective
Detailed Description:
Kidney transplantation has emerged as the treatment of choice for patients with end-stage renal disease ESRD Preliminary data suggest that IGIV therapy could have significant benefits in modifying allograft rejection episodes stabilizing long-term allograft function and reducing ischemiareperfusion injury
Qualified patients will have an in-vitro assessment of the ability of IGIV-C 10 to convert the donor-specific crossmatch cytotoxic assay from positive to negative Those patients with successful in-vitro conversion of the donor-specific crossmatch assay will be randomized to receive IGIV-C 10 intravenously at a dose of either 2 gmkg 1 gmkg or 05 gmkg IGIV-C 10 will be administered 3 to 5 days prior to planned transplantation and if transplantation is successful 7 days post-transplant If after receiving the IGIV-C infusion the donor-specific crossmatch reveals that cell death has fallen to 20 or less above background the crossmatch will be considered negative If after receiving one infusion the crossmatch remains positive additional IGIV-C infusions may be administered at one-month intervals up to 4 infusions A repeat crossmatch must be obtained after each infusion Patients will be followed for 12 months post-transplant Concomitant therapy will include a standard immunosuppression regimen of mycophenolate mofetil tacrolimus and prednisone following induction therapy with thymoglobulin
Qualified patients will have an in-vitro assessment of the ability of IGIV-C 10 to convert the donor-specific crossmatch cytotoxic assay from positive to negative Those patients with successful in-vitro conversion of the donor-specific crossmatch assay will be randomized to receive IGIV-C 10 intravenously at a dose of either 2 gmkg 1 gmkg or 05 gmkg IGIV-C 10 will be administered 3 to 5 days prior to planned transplantation and if transplantation is successful 7 days post-transplant If after receiving the IGIV-C infusion the donor-specific crossmatch reveals that cell death has fallen to 20 or less above background the crossmatch will be considered negative If after receiving one infusion the crossmatch remains positive additional IGIV-C infusions may be administered at one-month intervals up to 4 infusions A repeat crossmatch must be obtained after each infusion Patients will be followed for 12 months post-transplant Concomitant therapy will include a standard immunosuppression regimen of mycophenolate mofetil tacrolimus and prednisone following induction therapy with thymoglobulin
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