A Study of Factors That Affect Long-Term Kidney Transplant Function

NCT00270712

Last updated date
Study Location
University of Alabama - Division of Nephrology
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Transplant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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Advanced Information
Descriptive Information
Brief Title A Study of Factors That Affect Long-Term Kidney Transplant Function
Official Title Study of Long-term Deterioration of Kidney Allograft Function (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 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood and urine specimens.
Sampling Method Non-Probability Sample
Study Population Kidney transplant recipients
Condition Kidney Transplant
Intervention Not Provided
Study Groups/Cohorts
  • Retrospective Cohort
    537 transplant recipient records used retrospectively
  • Prospective Cohort
    3137 transplant recipients enrolled prospectively
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 14, 2013)
3175
Original Enrollment
 (submitted: December 27, 2005)
5000
Actual Study Completion Date December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00270712
Other Study ID Numbers 0407M62262
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Minnesota
Study Sponsor University of Minnesota
Collaborators
  • Astellas Pharma Inc
  • Bristol-Myers Squibb
  • Novartis
  • Pfizer
  • Sanofi
Investigators
Principal Investigator:Arthur J. Matas, MDUniversity of Minnesota
PRS Account University of Minnesota
Verification Date October 2019