Biomarkers of Aging as Predictors of Kidney Transplant Function
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | December 2015 |
Clinical Utility of Biomarkers of Aging as Predictors of Kidney Graft Function in Extended Criteria Organ Recipients
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.
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.
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.
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.
Inclusion Criteria:
- Donor > 35 years of age
Exclusion Criteria:
- Recipient is HIV positive
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