Recruiting

tGFR vs. Urine Collection

Sponsor:

Aaron Cook

Code:

NCT07643467

Conditions

Augmented Renal Clearance

Critical Illness

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Relmapirazin

Iohexol

Medibeacon tGFR monitor

Urine creatinine clearance collection

Study Details

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

Study ID

NCT07643467

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-65 years old
  • critically ill or acutely ill hospitalized patients admitted to the intensive care unit
  • Stable/normal renal function

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

Interventions

Relmapirazin

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

Iohexol

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

Medibeacon tGFR monitor

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

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.

Primary outcome measure

  • Transdermal Glomerular Filtration Rate (tGFR) Monitoring Accuracy [ Time Frame: 8 Hours ]

Central Contacts and Locations

Central contacts

Aaron Cook, PharmD

18592578444amcook0@uky.edu

Locations

UKHealthCare/University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

More Information

Sponsor

Aaron Cook

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Aaron Cook on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.