Biomarkers of Aging as Predictors of Kidney Transplant Function

March 6, 2016 updated by: Sapere Bio

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Hospitals
      • Winston-Salem, North Carolina, United States
        • Wake Forest Baptist Health, Abdominal Organ Transplant Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Renal Transplant Recipients at UNC Hospitals who received a single organ from a deceased donor (ECD, DCD, or SCD).

Description

Inclusion Criteria:

  • Donor > 35 years of age

Exclusion Criteria:

  • Recipient is HIV positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sapere Bio

Collaborators

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: David Gerber, MD, University of North Carolina- Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 7, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 9, 2015

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 6, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSDX-1501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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