Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to evaluate the effect of protein loading on the measurement of renal reserve using the MediBeacon Transdermal glomerular filtration rate (tGFR) system. Adults with estimated glomerular filtration rate (eGFR) >30 ml/min/1.73 m^2 will be recruited to join the study. This is a potential new use for the tGFR for the assessment of renal reserve. Renal reserve is the increase in GFR that occurs in response to various stimuli, such as when one kidney is removed. The remaining kidney will often show an increase in GFR to compensate. Renal reserve is typically measured after a high protein meal and requires a reproducible stimulus and a repeated measurement of GFR.
The main questions it aims to answer are:
Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace. On dosing day, participants will have the tGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon Transdermal GFR System initiated to collect background fluorescence. Following an injection of Lumitrace and the initiation of GFR assessments, participants will ingest a high protein meal over 15-20 minutes. They will be followed at the study center for up to 6-8 hours following administration of Lumitrace. All participants will participate in a follow-up phone call approximately 7 days after the last exposure to Lumitrace. Researchers will analyze the results to see if there is a detectable difference in fluorescence clearance rate following the high protein meal.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 130 mg Lumitrace | Experimental | Participants will have the TGFR sensor placed and background measurements initiated. Participants will then receive a single intravenous 130 mg dose of Lumitrace. Approximately three hours later, they will ingest a high protein meal consisting of approximately 1.25 g/kg in a protein shake over 15-20 minutes following a minimum of an 8 hour fast. They will be followed at the study center for up to 6-8 hours following administration of Lumitrace. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumitrace | Device | 18.6 mg/mL in a 7.0 mL volume administered by intravenous injection over 30 - 60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 - 60 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Renal reserve percentage | Renal reserve (%) will be calculated as Peak glomerular filtration rate (GFR) during the assessment period minus the average baseline GFR/average baseline GFR. | Day 1 |
Not provided
Not provided
Inclusion Criteria:
To be eligible for study entry, all participants must satisfy all of the following criteria:
Age > 18 years - male or female
Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
eGFR >30 mL/min/1.73 m^2
Capable of fasting for at least 8 hours prior to the evaluation day
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard B Dorshow, PhD | Contact | 314-735-0968 | rbdorshow@medibeacon.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard B Dorshow, PhD | MediBeacon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fletcher Allen Health Care, University of Vermont Medical School | Burlington | Vermont | 05401 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) | Device | Site staff will place and affix the TGFR reusable sensor and Disposable Ring for all enrolled participants. One sensor will be attached to the upper chest. An adhesive clip, surgical tape or other means may also be used to alleviate tension on the sensor cord. TGFR assessments will be collected for a minimum of 6 hours up to 8 hours post Lumitrace injection. |
|