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

Kidney Transplant Clinical Trial

— DeKAF  

Official title:

Study of Long-term Deterioration of Kidney Allograft Function (DeKAF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270712
• Other study ID #: 0407M62262
• Status: Completed
• Start date: October 2005
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3175
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Locations

Country	Name	City	State
Canada	University of Alberta - Division of Nephrology & Immunology	Edmonton	Alberta
Canada	Health Sciences Center - Section of Nephrology	Winnipeg	Manitoba
United States	University of Alabama - Division of Nephrology	Birmingham	Alabama
United States	University of Iowa - Nephrology Division	Iowa City	Iowa
United States	Hennepin County Medical Center - Division of Nephrology	Minneapolis	Minnesota
United States	University of Minnesota Dept of Surgery - Transplantation Division	Minneapolis	Minnesota
United States	Mayo Clinic - Division of Nephrology	Rochester	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
University of Minnesota	Astellas Pharma Inc, Bristol-Myers Squibb, Novartis, Pfizer, Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Hariharan S, Kasiske B, Matas A, Cohen A, Harmon W, Rabb H. Surrogate markers for long-term renal allograft survival. Am J Transplant. 2004 Jul;4(7):1179-83. — View Citation

Kasiske BL, Gaston RS, Gourishankar S, Halloran PF, Matas AJ, Jeffery J, Rush D. Long-term deterioration of kidney allograft function. Am J Transplant. 2005 Jun;5(6):1405-14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kidney transplant failure		throughout study (for prospective cohort)