Status:
COMPLETED
A Study of Factors That Affect Long-Term Kidney Transplant Function
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Astellas Pharma Inc
Bristol-Myers Squibb
Conditions:
Kidney Transplant
Eligibility:
All Genders
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 i...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Prospective Cohort:
- Received a kidney transplant within 10 days prior to study entry, on or after 10-01-2005
- Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
- Inclusion Criteria for Retrospective Cohort:
- Received a kidney transplant before 10-01-2005
- Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
- Undergoes a clinically indicated kidney biopsy due to new onset deterioration of function, defined as having an increase in serum creatinine
- The creatinine level on or before 01-01-2006 must be 2 mg/dl or less OR the patient must have developed new onset proteinuria, defined as having a protein/creatinine ratio of 0.4 or more
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
3175 Patients enrolled
Trial Details
Trial ID
NCT00270712
Start Date
October 1 2005
End Date
December 31 2018
Last Update
November 1 2019
Active Locations (7)
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1
University of Alabama - Division of Nephrology
Birmingham, Alabama, United States, 35294
2
University of Iowa - Nephrology Division
Iowa City, Iowa, United States, 52242
3
Hennepin County Medical Center - Division of Nephrology
Minneapolis, Minnesota, United States, 55415
4
University of Minnesota Dept of Surgery - Transplantation Division
Minneapolis, Minnesota, United States, 55455