NCT02084966

Brief Summary

Optical coherence tomography (OCT) is a rapidly emerging imaging modality that can function as a type of "optical biopsy", providing non-invasive cross-sectional images of tissue architectural morphology in situ and in real-time. This proposal will demonstrate that OCT has the ability to provide novel and valuable histopathological information regarding donor kidneys that can be used to predict post-transplant renal function. These investigations will result in a major breakthrough in increasing the number of healthy kidneys available for transplantation by making the most efficient use of available donor kidneys, eliminating the possible use of bad donor kidneys, providing an accurate measure of expected post-transplant renal function, and allowing better distinction between post-transplant immunological rejection and ischemic-induced acute renal failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 8, 2019

Status Verified

March 1, 2019

Enrollment Period

4.7 years

First QC Date

March 6, 2014

Last Update Submit

March 6, 2019

Conditions

Chronic Kidney Disease

Keywords

KidneyTransplantationImagingRenal functionOptical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

  • Non-Invasive Evaluation of Transplant Kidney using OCT

    The outcome from these studies is to show significance differences in the donor kidneys of the three patient populations (i.e., immediate graft function, slow graft function and delayed graft function) using OCT imaging.

    Up to 4 years

Study Arms (1)

OCT Imaging

EXPERIMENTAL

OCT imaging of the kidneys prior to and following their transplant

Procedure: Procedure/Surgery: Transplantation: OCT of Kidney Transplant

Interventions

Procedure/Surgery: Transplantation: OCT of Kidney TransplantPROCEDURE

Device: Optical Coherence Tomography of Kidney Transplant

OCT Imaging

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 12, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 8, 2019

Record last verified: 2019-03

Locations

US(1)