A Study of Factors That Affect Long-Term Kidney Transplant Function (DeKAF)
The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.
|Study Design:||Observational Model: Cohort|
|Official Title:||Study of Long-term Deterioration of Kidney Allograft Function (DeKAF)|
- Kidney transplant failure [ Time Frame: throughout study (for prospective cohort) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood and urine specimens.
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
537 transplant recipient records used retrospectively
3137 transplant recipients enrolled prospectively
Over time, chronic kidney graft dysfunction progressively threatens the long-term survival of a kidney graft. The disease processes behind graft dysfunction are unclear. However, chronic kidney graft dysfunction is likely to be caused by certain definable factors. Such factors may include collagens III and IV, transforming growth factor (TGF)-beta, T and B cell surface markers, cell cycle proteins, fibronectin, and laminin. Determining what disease processes and which specific factors are most responsible for kidney graft dysfunction may help in designing future interventional trials for kidney transplant patients. The purpose of this study is to determine whether clinical, laboratory, and histologic studies at the time of initial graft dysfunction will clarify the processes and factors that lead to deterioration and loss of a kidney graft. This is an observational study that will enroll participants who have recently received kidney transplants (prospective cohort) and participants who have had kidney transplants for a longer period of time and are now experiencing kidney graft dysfunction (retrospective cohort).
The duration of this trial may differ between participants, depending on when deterioration of kidney graft function occurs. Participants will be followed until graft loss or death. There are no exclusive study visits associated with this study. Study data are gathered from routine laboratory follow-up tests completed at the participant's local medical center and from information obtained at the time of kidney biopsy. Participants may need to undergo a kidney biopsy as clinically indicated. At the time of biopsy, participants will also undergo urine and blood collection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270712
|United States, Alabama|
|University of Alabama - Division of Nephrology|
|Birmingham, Alabama, United States, 35294|
|United States, Iowa|
|University of Iowa - Nephrology Division|
|Iowa City, Iowa, United States, 52242|
|United States, Minnesota|
|University of Minnesota Dept of Surgery - Transplantation Division|
|Minneapolis, Minnesota, United States, 55455|
|Hennepin County Medical Center - Division of Nephrology|
|Minneapolis, Minnesota, United States, 55415|
|Mayo Clinic - Division of Nephrology|
|Rochester, Minnesota, United States, 55905|
|University of Alberta - Division of Nephrology & Immunology|
|Edmonton, Alberta, Canada, T6G 2S2|
|Health Sciences Center - Section of Nephrology|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||Arthur J. Matas, MD||University of Minnesota - Clinical and Translational Science Institute|