Biomarkers of Aging as Predictors of Kidney Transplant Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Delayed Graft Function, Other Complications of Kidney Transplant

Intervention / Treatment
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* Other: No treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donor > 35 years of age Exclusion Criteria: Recipient is HIV positive

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No treatment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slow graft function (SGF; decline in serum creatinine >20% within 24h after transplant, no dialysis) |  | 24h | 
| Delayed graft function (DGF; need for dialysis during first week after transplant) |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term graft function measured by change in serum creatinine (delta1-12eGFR) |  | 12 months | 
| Long-term graft function measured by change in serum creatinine (delta1-6eGFR) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed Graft Function, Slow Graft Function, Renal Transplant, Extended Criteria Donor, Biomarker of Aging, Kidney Transplant