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| 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) |
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
|
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 |
Kidney transplant recipients
Inclusion Criteria for Prospective Cohort:
Inclusion Criteria for Retrospective Cohort:
Contacts and Locations| Contact: Arthur J. Matas, MD | 612-625-6460 | matas001@umn.edu |
| Contact: Lois E. McHugh, MS, RN | 612-625-3601 | mchug001@umn.edu |
| 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 | |
| Principal Investigator: | Arthur J. Matas, MD | University of Minnesota - Clinical and Translational Science Institute |
More Information
| 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 |
|
kidney transplant dysfunction |
chronic deterioration loss of function |