search
Back to results

Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring

Primary Purpose

Kidney Diseases, Kidney Injury, Kidney Failure

Status
Suspended
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MB-102
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Sponsored by
MediBeacon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Diseases focused on measuring Glomerular Filtration Rate, Relmapirazin, Iohexol, Pharmacokinetics, Transdermal fluorescence detection, MB-102

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose For women of childbearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization Men will not donate sperm during the study and for 1 month following the last dose of study drug. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol Adequate venous access sufficient to allow blood sampling per protocol requirements Exclusion Criteria: Participants positive for COVID-19 at the time of dosing Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing The participant has participated in a clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer). History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape) History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 or other related products (intolerance to a drug is not considered a drug allergy). Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial Significant scaring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day Use make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the participant at increased risk or compromise the interpretability of study results. Currently receiving dialysis Currently anuric Positive serum pregnancy test Participants with an eGFR > 120 mL/min/1.73m^2

Sites / Locations

  • Research by Design, LLC
  • PPD
  • Clinical Advancement Center, PLLC
  • Endeavor Clinical Trials, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participants with eGFR ≥ 70 mL/min/1.73 m^2

Participants with eGFR < 70 mL/min/1.73 m^2

Arm Description

MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.

Outcomes

Primary Outcome Measures

Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)
Statistical agreement between tGFR and nGFR will be calculated.

Secondary Outcome Measures

Number of participants with treatment-emergent adverse events associated with MB-102 administration
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
Number of participants with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.

Full Information

First Posted
March 8, 2023
Last Updated
August 29, 2023
Sponsor
MediBeacon
search

1. Study Identification

Unique Protocol Identification Number
NCT05777174
Brief Title
Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring
Official Title
An Open Label, Multi-Center, Safety and Pharmacokinetic Bridging Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Sponsor is submitting an IDE amendment and the study is expected to resume in October 2023.
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediBeacon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to establish that the MB-102 transdermal fluorescence-measured Glomerular Filtration Rate (GFR) using the MediBeacon® Measurement System with the Transdermal Glomerular Filtration Rate (TGFR) reusable sensor with disposable adhesive ring is comparable to the plasma-measured MB-102 GFR in normal and compromised renal function participants with different skin color types.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Diseases, Kidney Injury, Kidney Failure
Keywords
Glomerular Filtration Rate, Relmapirazin, Iohexol, Pharmacokinetics, Transdermal fluorescence detection, MB-102

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with eGFR ≥ 70 mL/min/1.73 m^2
Arm Type
Experimental
Arm Description
MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR ≥ 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
Arm Title
Participants with eGFR < 70 mL/min/1.73 m^2
Arm Type
Experimental
Arm Description
MB-102 (130 mg) will be administered to participants with estimated glomerular filtration rate (eGFR) eGFR < 70 mL/min/1.73 m^2, and fluorescence measured using the MediBeacon Transdermal GFR Measurement System. Approximately half of the participants are to be enrolled with Fitzpatrick Scale Type I, II or III, and half with Type IV, V and VI skin color type.
Intervention Type
Drug
Intervention Name(s)
MB-102
Other Intervention Name(s)
Relmapirazin
Intervention Description
130 mg administered by intravenous injection over 30-60 seconds, followed by a 10 mL normal saline flush administered intravenously over 30-60 seconds.
Intervention Type
Device
Intervention Name(s)
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Intervention Description
On treatment day, participants will have the TGFR reusable sensor with disposable adhesive ring placed on their chest, and the MediBeacon® Transdermal GFR Measurement System will be initiated to collect background fluorescence. When this is completed, participants will then receive a single dose of MB-102. Fluorescent measurements will be collected for 12-24 hours. For those with significant renal compromise, fluorescent measurements will continue until the sensor no longer detects MB-102 in the body.
Primary Outcome Measure Information:
Title
Correlation of transdermal derived glomerular filtration rate (tGFR) to the plasma-derived indexed glomerular filtration rate (nGFR)
Description
Statistical agreement between tGFR and nGFR will be calculated.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events associated with MB-102 administration
Description
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
Time Frame
Up to 10 days
Title
Number of participants with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device
Description
An adverse event is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, temporally associated with the use of a medicinal product, whether or not related to the investigational medical device or drug.
Time Frame
Up to 10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible female non-pregnant participants who are either not of child-bearing potential or willing to use adequate contraception during the trial Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post-dose For women of childbearing potential, the participant should have a negative serum pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system or male partner sterilization Men will not donate sperm during the study and for 1 month following the last dose of study drug. Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol Adequate venous access sufficient to allow blood sampling per protocol requirements Exclusion Criteria: Participants positive for COVID-19 at the time of dosing Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication Non-steroidal anti-inflammatory (NSAID) use within 3 days of MB-102 dosing The participant has participated in a clinical trial and has received an investigational product within the following time ranges: prior to the first dosing day in the current study: either 30 days or 5 half-lives of the investigational product (whichever duration is longer). History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape) History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 or other related products (intolerance to a drug is not considered a drug allergy). Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial Significant scaring, tattoos or alterations in pigmentation on the sternum or other sensor location testing areas that would alter sensor readings versus other areas of the skin Use of tanning sprays, tanning products etc. on the upper chest within 2 weeks of dosing day Use make-up, lotions, Vaseline or other products on the area of the upper chest on the day prior to or the day of dosing Any serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the participant at increased risk or compromise the interpretability of study results. Currently receiving dialysis Currently anuric Positive serum pregnancy test Participants with an eGFR > 120 mL/min/1.73m^2
Facility Information:
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
PPD
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring

We'll reach out to this number within 24 hrs