Biomarkers of Aging as Predictors of Kidney Transplant Function

Completed

• Conditions: Delayed Graft Function; Other Complications of Kidney Transplant

• Registration Number: NCT02335333
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-07
• Study First Posted: 2015-01-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-06
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Donor > 35 years of age

Exclusion Criteria

• Recipient is HIV positive

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Delayed graft function (DGF; need for dialysis during first week after transplant)	1 week
Slow graft function (SGF; decline in serum creatinine >20% within 24h after transplant, no dialysis)	24h

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

UNC Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States

Wake Forest Baptist Health, Abdominal Organ Transplant Program; 🇺🇸 Winston-Salem, North Carolina, United States