NCT02335333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

January 7, 2015

Last Update Submit

March 6, 2016

Conditions

Delayed Graft FunctionOther Complications of Kidney Transplant

Keywords

Delayed Graft FunctionSlow Graft FunctionRenal TransplantExtended Criteria DonorBiomarker of AgingKidney Transplant

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Interventions

No treatmentOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Donor \> 35 years of age

You may not qualify if:

  • Recipient is HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNC Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Health, Abdominal Organ Transplant Program

Winston-Salem, North Carolina, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

T lymphocytes, plasma and white blood cells isolated from peripheral blood sample will be stored.

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Gerber, MD

    University of North Carolina- Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

January 9, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 8, 2016

Record last verified: 2016-03

Locations

US(2)