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NCT Number: NCT02335333

Biomarkers of Aging as Predictors of Kidney Transplant Function

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Hospitals, Chapel Hill, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Donor > 35 years of age

Exclusion criteria

  • Recipient is HIV positive

Treatment and study plan

No treatment

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sapere Bio

Industry

Collaborators

  • University of North Carolina, Chapel Hill

Registry information

Official study title

Clinical Utility of Biomarkers of Aging as Predictors of Kidney Graft Function in Extended Criteria Organ Recipients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2015
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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