Biomarkers of Aging as Predictors of Kidney Transplant Function

Delayed Graft Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335333
• Other study ID #: HSDX-1501
• Status: Completed
• Phase: N/A
• First received: January 7, 2015
• Last updated: March 6, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: HealthSpan Dx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Donor > 35 years of age

Exclusion Criteria:

• Recipient is HIV positive

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delayed Graft Function
• Other Complications of Kidney Transplant

Intervention

Other:
• No treatment

Locations

Country	Name	City	State
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Wake Forest Baptist Health, Abdominal Organ Transplant Program	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
HealthSpan Dx	University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slow graft function (SGF; decline in serum creatinine >20% within 24h after transplant, no dialysis)		24h	No
Primary	Delayed graft function (DGF; need for dialysis during first week after transplant)		1 week	No
Secondary	Long-term graft function measured by change in serum creatinine (delta1-12eGFR)		12 months	No
Secondary	Long-term graft function measured by change in serum creatinine (delta1-6eGFR)		6 months	No