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A Study of Factors That Affect Long-Term Kidney Transplant Function (DeKAF)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by National Institute of Allergy and Infectious Diseases (NIAID).   Recruitment status was  Recruiting

First Received on December 27, 2005.   Last Updated on May 28, 2008   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270712
  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 National Institute of Allergy and Infectious Diseases (NIAID):

Biospecimen Retention:   Samples With DNA

Blood and urine specimens.


Estimated Enrollment: 5000
Study Start Date: October 2005
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Retrospective Cohort
2
Prospective Cohort

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

Contacts
Contact: Arthur J. Matas, MD 612-625-6460 matas001@umn.edu
Contact: Lois E. McHugh, MS, RN 612-625-3601 mchug001@umn.edu

Locations
United States, Alabama
University of Alabama - Division of Nephrology Recruiting
Birmingham, Alabama, United States, 35294
Contact: Robert Gaston, MD     205-934-7220     rgaston@uab.edu    
Contact: Wendy Bailey     205-934-7220     wbailey@uab.edu    
Principal Investigator: Robert Gaston, MD            
United States, Iowa
University of Iowa - Nephrology Division Recruiting
Iowa City, Iowa, United States, 52242
Contact: Lawrence Hunsicker, MD     319-356-4763     lawrence-hunsicker@uiowa.edu    
Contact: Wendy Wallace         wendy-wallace@uiowa.edu    
Principal Investigator: Lawrence Hunsicker, MD            
United States, Minnesota
University of Minnesota Dept of Surgery - Transplantation Division Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Arthur J. Matas, MD     612-625-6460     matas001@umn.edu    
Contact: Lois E. McHugh, MS, RN     612-625-3601     mchug001@umn.edu    
Principal Investigator: Arthur J. Matas, MD            
Hennepin County Medical Center - Division of Nephrology Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Bertram Kasiske, MD     612-347-5871     kasis001@umn.edu    
Contact: Theresa Anderson-Haag, PharmD     612-347-7797     Teresa.Anderson-Haag@co.hennepin.mn.us    
Principal Investigator: Bertram Kasiske, MD            
Mayo Clinic - Division of Nephrology Recruiting
Rochester, Minnesota, United States, 55905
Contact: Fernando G. Cosio, MD     507-266-1963     Cosio.Fernando@mayo.edu    
Contact: Jennie A. Wilson, RN     507-284-6814     wilson.jennie@mayo.edu    
Principal Investigator: Fernando G. Cosio, MD            
Canada, Alberta
University of Alberta - Division of Nephrology & Immunology Recruiting
Edmonton, Alberta, Canada, T6G 2S2
Contact: Philip Halloran, MD, PhD     780-407-8880     phil.halloran@ualberta.ca    
Contact: Pamela Publicover     780-407-8880     pam.publicover@ualberta.ca    
Principal Investigator: Philip Halloran, MD, PhD            
Sub-Investigator: Sita Gourishankar, MD            
Canada, Manitoba
Health Sciences Center - Section of Nephrology Recruiting
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: David Rush, MD     204-787-3437     drush@exchange.hsc.mb.ca    
Contact: Myrna Ross         mdross@hsc.mb.ca    
Principal Investigator: David Rush, MD            
Sponsors and Collaborators
Investigators
Principal Investigator: Arthur J. Matas, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: Arthur J. Matas / Director of Renal Transplantation, University of Minnesota, Department of Surgery
ClinicalTrials.gov Identifier: NCT00270712     History of Changes
Other Study ID Numbers: R01AI058013, R01-AI058013
Study First Received: December 27, 2005
Last Updated: May 28, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
kidney
transplant
dysfunction
chronic
deterioration
loss of function

ClinicalTrials.gov processed this record on February 09, 2012