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Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
International
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 other trial for Chronic Kidney Disease focused on measuring Glomerular Filtration Rate, Transdermal fluorescence detection, Relmapirazin

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 child-bearing 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 via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site)
  • 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
  • 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
  • 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

  • Velocity Clinical Research
  • Research by Design, LLC
  • Nucleus Network
  • Carolina Phase I Research
  • Endeavor Clinical Trials, LLC
  • West China Hospital of Sichuan University
  • Peking University First Hospital
  • Affiliated Hospital of Xuzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

eGFR ≥ 70 mL/min/1.73 m^2

eGFR < 70 mL/min/1.73 m^2

Arm Description

Participants with eGFR ≥ 70 mL/min/1.73 m^2 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 12 hours.

Participants with eGFR < 70 mL/min/1.73 m^2 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 24 hours.

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
April 21, 2022
Last Updated
March 24, 2023
Sponsor
MediBeacon
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1. Study Identification

Unique Protocol Identification Number
NCT05425719
Brief Title
Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects
Official Title
A Pivotal, Open Label, Multi-Center, Safety and Pharmacokinetic Study of MB-102 (Relmapirazin) and the Use of the MediBeacon Transdermal GFR Measurement System in Normal and Renal Compromised Subjects for the Evaluation of Kidney Function
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)

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
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-center, open-label, pivotal study comparing transdermal glomerular filtration rate (tGFR) to plasma-derived indexed GFR (nGFR) with MB-102 (relmapirazin) as the fluorophore. Participants will span the GFR range of values from normal to stage 4 chronic kidney disease (CKD) and span the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS). The safety and pharmacokinetics of MB-102 and the safety of the MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) will also be evaluated.
Detailed Description
Approximately 50% of participants will have GFR > 70 mL/min/1.73m^2, and approximately 50% of participants will have GFR < 70 mL/min/1.73m^2. Approximately 50% of participants enrolled in the United States will have a FSS value of I-III, and 50% of participants will be FSS IV-VI. The FSS stratification will not apply to participants enrolled in China because the population demographic is unlikely to support the full FSS spectrum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Glomerular Filtration Rate, Transdermal fluorescence detection, Relmapirazin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eGFR ≥ 70 mL/min/1.73 m^2
Arm Type
Experimental
Arm Description
Participants with eGFR ≥ 70 mL/min/1.73 m^2 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 12 hours.
Arm Title
eGFR < 70 mL/min/1.73 m^2
Arm Type
Experimental
Arm Description
Participants with eGFR < 70 mL/min/1.73 m^2 will receive one 130 mg dose of MB-102 and a transdermal sensor placed on their chest. Blood samples and fluorescent measurements will be collected over 24 hours.
Intervention Type
Drug
Intervention Name(s)
MB-102
Other Intervention Name(s)
Relmapirazin
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR)
Intervention Description
On treatment day, participants will have a transdermal sensor placed on their chest in the area between the shoulders (including the pectoralis and sternum area), and the MediBeacon Transdermal GFR Measurement System will be initiated to collect background fluorescence. After collection of background fluorescence, participants will then receive a single dose of MB-102.
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 child-bearing 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 via PCR testing for COVID-19 (Vaccinated participants without symptoms of COVID-19 are not required to undergo PCR testing but may be tested at the discretion of the study site) 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 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Dorshow, PhD
Organizational Affiliation
MediBeacon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Velocity Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Research by Design, LLC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60643
Country
United States
Facility Name
Nucleus Network
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
Carolina Phase I Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610093
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
ZIP/Postal Code
2210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pharmacokinetics and Safety of MB-102 (Relmapirazin) and the MediBeacon Transdermal GFR Measurement System in Evaluation of Kidney Function in Normal and Renal Compromised Subjects

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