Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270712
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2005-12-27
Brief Title:
A Study of Factors That Affect Long-Term Kidney Transplant Function
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Study of Long-term Deterioration of Kidney Allograft Function DeKAF
Status:
COMPLETED
Status Verified Date:
2019-10
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:
DeKAF
Brief Summary:
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
Detailed Description:
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 participants 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
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 participants 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
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