Fluorescent Probe for Assessment of Renal Elimination

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Aaron Cook
Study ID
NCT07643467
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Augmented Renal Clearance
  • Critical Illness

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Relmapirazin — DRUG
    IV push of relmapirazin (Lumitrace) prior to use of the tGFR device
  • 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 tGFR monitor — DEVICE
    The tGFR monitor will be applied to the patient after relmapirazin bolus for measurement of GFR.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: MediBeacon Transdermal Glomerular Filtration Rate (GFR) Monitoring

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UKHealthCare/University of KentuckyLexingtonKentucky40536-

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By research site
UKHealthCare/University of Kentucky· Lexington, KY

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