Fluorescent Probe for Assessment of Renal Elimination

NCT07643467 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 105008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Transdermal Glomerular Filtration Rate (tGFR) Monitoring Accuracy

  Accuracy of transdermal glomerular filtration rate (GFR) monitoring compared with measured urine creatinine clearance.

  8 Hours

Secondary Outcomes (2)

• Relmapirazin Elimination Half-Life

  12 hours

• Iohexol Elimination Half-Life

  12 hours

Study Arms (1)

MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

EXPERIMENTAL

Drug: Relmapirazin; Drug: Iohexol; Device: Medibeacon tGFR monitor; Diagnostic Test: Urine creatinine clearance collection

Interventions

Iohexol DRUG

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

MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

Medibeacon tGFR monitor DEVICE

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

MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

Relmapirazin DRUG

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

MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

Urine creatinine clearance collection DIAGNOSTIC_TEST

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

MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• critically ill or acutely ill hospitalized patients admitted to the intensive care unit
• Stable/normal renal function

You may not qualify if:

• Prisoners
• Pregnant women
• Laboratory evidence of unstable kidney function (KDIGO AKI stage 1-3--This includes subjects with Scr \> 1.5x baseline)

Sponsors & Collaborators

• Aaron Cook: lead

Study Sites (1)

UKHealthCare/University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

relmapirazin; Iohexol

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Aaron M Cook, PharmD

  University of Kentucky College of Pharmacy, Department of Pharmacy Practice & Science

  PRINCIPAL INVESTIGATOR

• Juan-Carlos Aycinena, MD

  University of Kentucky College of Medicine, Department of Nephrology

  STUDY DIRECTOR

Central Study Contacts

Aaron Cook, PharmD

CONTACT

18592578444; amcook0@uky.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: June 11, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

US (1)