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Biomarkers of Aging as Predictors of Kidney Transplant Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02335333
Recruitment Status : Completed
First Posted : January 9, 2015
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Sapere Bio

Brief Summary:
The primary purpose of this study is to measure the correlation between baseline expression of aging biomarkers, SenesceTest in blood of organ donor and renal graft function. This pilot study will study patients who are undergoing renal transplantation with organs from extended criteria donors, standard criteria donors or donation after cardiac death and compare ability of SenesceTest to predict renal graft function immediately after the transplant and at 1 year followup.

Condition or disease Intervention/treatment
Delayed Graft Function Other Complications of Kidney Transplant Other: No treatment

Detailed Description:

Presently, donated organs are ranked amongst each other based on a formula for Kidney Donor Patient Index (KDPI; a variation of Donor Risk index) 8 which includes donor demographics and clinical history but no molecular markers of kidney function other than serum creatinine. Using KDPI assessment, nearly all ECD kidneys fall into the high-risk category. And while ECD kidneys are associated with higher risk of graft failure, studies note a wide variability in ECD organ quality and the associated graft survival (half-life graft survival 4.5-7.9 years), suggesting that current models of assessing organ quality are inadequate. Furthermore, prior to even being assigned a KDPI, over 37% of all kidneys and over 50% of ECD kidneys are discarded based on biopsy findings. However, recent studies called into question the reliance on procurement kidney biopsy reports in making acceptance decisions by demonstrating significant overlap in the biopsy findings between discarded and transplanted kidneys. The use of ECD kidneys is becoming more widespread and, according to a recent report, 70% adults >65yo and 50% adults between 50 and 64 yo are willing to accept an ECD kidney. Therefore, new methodology for assessment of graft viability would increase transplantation rates particularly for organs from older or expanded criteria donors, shorten patient's time on wait list (currently 45 months average 50) and improve their outcomes by taking them off dialysis sooner.

Here, we propose a new approach—using molecular age markers (collectively referred to as SenesceTest) to predict kidney graft function.

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Utility of Biomarkers of Aging as Predictors of Kidney Graft Function in Extended Criteria Organ Recipients
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Slow graft function (SGF; decline in serum creatinine >20% within 24h after transplant, no dialysis) [ Time Frame: 24h ]
  2. Delayed graft function (DGF; need for dialysis during first week after transplant) [ Time Frame: 1 week ]

Secondary Outcome Measures :
  1. Long-term graft function measured by change in serum creatinine (delta1-12eGFR) [ Time Frame: 12 months ]
  2. Long-term graft function measured by change in serum creatinine (delta1-6eGFR) [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
T lymphocytes, plasma and white blood cells isolated from peripheral blood sample will be stored.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Renal Transplant Recipients at UNC Hospitals who received a single organ from a deceased donor (ECD, DCD, or SCD).
Criteria

Inclusion Criteria:

  • Donor > 35 years of age

Exclusion Criteria:

  • Recipient is HIV positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335333


Locations
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United States, North Carolina
UNC Hospitals
Chapel Hill, North Carolina, United States, 27599
Wake Forest Baptist Health, Abdominal Organ Transplant Program
Winston-Salem, North Carolina, United States
Sponsors and Collaborators
Sapere Bio
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: David Gerber, MD University of North Carolina- Department of Surgery

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Responsible Party: Sapere Bio
ClinicalTrials.gov Identifier: NCT02335333    
Other Study ID Numbers: HSDX-1501
First Posted: January 9, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Keywords provided by Sapere Bio:
Delayed Graft Function
Slow Graft Function
Renal Transplant
Extended Criteria Donor
Biomarker of Aging
Kidney Transplant
Additional relevant MeSH terms:
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Delayed Graft Function
Pathologic Processes