Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419575
Status:
COMPLETED
Last Update Posted:
2008-06-05
First Post:
2007-01-05
Brief Title:
Renal Transplantation With Immune Monitoring
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Renal Transplantation With Immune Monitoring
Status:
COMPLETED
Status Verified Date:
2008-06
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 aim of this observational study is to evaluate an FDA approved immune system monitoring assay Immunknow Cylex Inc Columbia MD in renal transplant recipients using standard immunosuppression and prophylaxis protocols from the time of transplantation through a twelve month follow-up period The primary endpoint will be the incidence of acute rejection and infection and any correlation of these events to an assay that may be a measure of recipient immune response Secondary endpoints will include evaluation of renal function patient and graft survival incidence of post-transplantation lymphoproliferative disorder and duration and extent of lymphocyte depletion
Detailed Description:
As compared to previous eras renal transplantation is a procedure associated with low acute rejection rates and excellent one year graft survival Despite this success long term graft survival rates have not improved significantly The reasons for late graft loss are multi-factorial but include chronic rejection and infection Thus avoidance of chronic over immunosuppression is tantamount in avoiding graft or patient threatening infection while avoidance of under immunosuppression is necessary to prevent graft loss from acute or chronic rejection Renal allograft loss from a particular viral pathogen BK virus has become evident in the era of modern immunosuppression and likely reflects relative over immunosuppression We and others have used BK detection as an imprecise marker of over immunosuppression to help guide adjustments in chronic immunosuppressive therapy While screening for the presence of BK virus is helpful in avoiding over immunosuppression and potential graft loss from BK nephropathy a correlate assay is not readily available that provides evidence of under immunosuppression indicating risk of graft loss from rejection
At present a proven assay to measure the strength of the immune system is unavailable and the only definite markers of over or under-immunosuppression remain infection and rejection respectively A tool to help tailor chronic immunosuppressive therapy and decrease the incidence of either of these two extremes would be of significant value in helping to prolong allograft survival and decrease the risk of immunosuppressive therapy in renal transplant recipients
In this observational study we plan to use a standard immunosuppressive regimen as well as standard infection prophylaxis with the addition of an immune monitoring assay ImmunoKnow This assay measures ATP production by recipient T cells and has been proposed as a marker of immune function While of interest there are as yet no published studies describing the utility of this test for immune monitoring in adult renal transplant recipients As this assay remains unproven as a viable tool to define over or under immunosuppression we will be blinded to the ImmunoKnow results during the course of the study The results from the immune monitoring assay will only be used in a retrospective analysis to determine if there is any clinically relevant correlation between the values obtained and episodes of rejection infection or the development of donor specific antibodies If a significant correlation is suggested further evaluation in subsequent studies and eventual incorporation into prospective patient care may be warranted
At present a proven assay to measure the strength of the immune system is unavailable and the only definite markers of over or under-immunosuppression remain infection and rejection respectively A tool to help tailor chronic immunosuppressive therapy and decrease the incidence of either of these two extremes would be of significant value in helping to prolong allograft survival and decrease the risk of immunosuppressive therapy in renal transplant recipients
In this observational study we plan to use a standard immunosuppressive regimen as well as standard infection prophylaxis with the addition of an immune monitoring assay ImmunoKnow This assay measures ATP production by recipient T cells and has been proposed as a marker of immune function While of interest there are as yet no published studies describing the utility of this test for immune monitoring in adult renal transplant recipients As this assay remains unproven as a viable tool to define over or under immunosuppression we will be blinded to the ImmunoKnow results during the course of the study The results from the immune monitoring assay will only be used in a retrospective analysis to determine if there is any clinically relevant correlation between the values obtained and episodes of rejection infection or the development of donor specific antibodies If a significant correlation is suggested further evaluation in subsequent studies and eventual incorporation into prospective patient care may be warranted
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