Renal Transplantation With Immune Monitoring
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|ClinicalTrials.gov Identifier: NCT00419575|
Recruitment Status : Completed
First Posted : January 8, 2007
Last Update Posted : June 5, 2008
|Condition or disease|
|Renal Transplantation Immunosuppression|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Renal Transplantation With Immune Monitoring|
|Study Start Date :||October 2006|
|Actual Study Completion Date :||May 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419575
|United States, Missouri|
|Washington University School of Medicine/Barnes-Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Matthew J Koch, MD||Washington University School of Medicine|