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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00270712
First received: December 27, 2005
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition
Kidney Transplant

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Study of Long-term Deterioration of Kidney Allograft Function (DeKAF)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Kidney transplant failure [ Time Frame: throughout study (for prospective cohort) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and urine specimens.


Enrollment: 3175
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)
Groups/Cohorts
Retrospective Cohort
537 transplant recipient records used retrospectively
Prospective Cohort
3137 transplant recipients enrolled prospectively

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Kidney transplant recipients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270712

Locations
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
Canada, Alberta
University of Alberta - Division of Nephrology & Immunology
Edmonton, Alberta, Canada, T6G 2S2
Canada, Manitoba
Health Sciences Center - Section of Nephrology
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Arthur J. Matas, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00270712     History of Changes
Other Study ID Numbers: DAIT DeKAF
Study First Received: December 27, 2005
Last Updated: October 24, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
kidney
transplant
dysfunction
chronic
deterioration
loss of function

ClinicalTrials.gov processed this record on September 16, 2014