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Fluorescent Probe for Assessment of Renal Elimination

NCT07643467 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-09-03

No results posted yet for this study

Summary

Accurate measures of kidney function is important for precision dosing of many medications. The current methods of determining kidney function largely hinge on the use of equations that use common laboratory values such as serum creatinine \& static variables like age \& weight. These are helpful for trending over time, but often are inaccurate during times of medical illness. Other more accurate methods of measuring kidney function include urine collection, although this is not commonly used because of various reasons that make the collection inconvenient or unreliable. The new transdermal glomerular filtration (tGFR) device permits accurate, real-time evaluation of kidney function. This novel method has not been rigorously compared with urine collection \& other methods of determining kidney function in hospitalized patients. The goal of the study is to compare tGFR with other accepted methods of determining kidney function.

Conditions

  • Augmented Renal Clearance
  • Critical Illness

Interventions

DRUG

Relmapirazin

IV push of relmapirazin (Lumitrace) prior to use of the tGFR device

DRUG

Iohexol

Small IV push bolus of iohexol as a probe for renal function will be administered prior to use of the tGFR device.

DEVICE

Medibeacon tGFR monitor

The tGFR monitor will be applied to the patient after relmapirazin bolus for measurement of GFR.

DIAGNOSTIC_TEST

Urine creatinine clearance collection

8-hour urine creatinine clearance collection will be performed during the study period to compare to tGFR \& other renal function measures.

Sponsors & Collaborators

  • Aaron Cook

    lead OTHER

Principal Investigators

  • Aaron M Cook, PharmD · University of Kentucky College of Pharmacy, Department of Pharmacy Practice & Science

  • Juan-Carlos Aycinena, MD · University of Kentucky College of Medicine, Department of Nephrology

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-05-31
Completion
2028-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07643467 on ClinicalTrials.gov