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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 8
- 主要终点
- Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values
研究概览
简要总结
The goal of this clinical trial was to compare transdermal glomerular filtration rate (tGFR) to plasma-derived indexed (to body surface area; BSA) GFR (nGFR) using MB-102 (relmapirazin) as the fluorescent compound. Adults with kidney function ranging from normal to Stage 4 chronic kidney disease (CKD) and participants spanning the entire range of human skin colors as defined by the Fitzpatrick Skin Scale (FSS) were included in the study.
The main questions that the study aimed to answer were:
- To establish that the MB-102 transdermal fluorescence measured GFR using the MediBeacon Transdermal GFR Measurement System is comparable to the measured MB-102 plasma GFR
- To evaluate the safety and tolerability of a single dose of MB-102 in study participants
- To evaluate the safety and effectiveness of the MediBeacon Transdermal GFR Measurement System (TGFR) for the non-invasive transdermal fluorescence detection of MB-102 in participants
Participants had a transdermal sensor placed on their upper chest, and the TGFR collected background fluorescence. Participants then received a single dose of MB-102. Blood samples were collected and fluorescent measurements were taken over a 12- to 24-hour period. Following completion of the treatment period, participants returned to the study center approximately 1 week later for a safety follow-up visit. Researchers compared the results to see if the transdermal GFR measurements were comparable to the measured plasma GFR in those with and without normal kidney function and different skin coloration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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 scarring, 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
研究组 & 干预措施
eGFR ≥ 70 mL/min/1.73 m^2
Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
干预措施: MB-102 (Drug)
eGFR ≥ 70 mL/min/1.73 m^2
Participants with eGFR ≥ 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 12 hours.
干预措施: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) (Device)
eGFR < 70 mL/min/1.73 m^2
Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.
干预措施: MB-102 (Drug)
eGFR < 70 mL/min/1.73 m^2
Participants with eGFR < 70 mL/min/1.73 m^2 received one 130 mg dose of MB-102 and a transdermal sensor was placed on their chest. Blood samples and fluorescent measurements were collected over 24 hours.
干预措施: MediBeacon Transdermal Glomerular Filtration Rate Measurement System (TGFR) (Device)
结局指标
主要结局
Proportion of Transdermal Derived Glomerular Filtration Rate (tGFR) Values Within 30% of the nGFR Plasma-derived Indexed Glomerular Filtration Rate (nGFR) Values
时间窗: Up to 24 hours following the study dose
The performance measure of P30 is defined as the proportion of transdermal derived GFR values that are within 30% of the measured plasma-derived GFR. The comparison of transdermal derived glomerular filtration rate (tGFR) with respect to the plasma-derived indexed glomerular filtration rate (nGFR) was calculated with a double-sided 95% confidence interval (CI). The performance goal was 0.85, and success for the study was defined as a lower limit of the 95% CI greater than 0.85.
次要结局
- Number of Participants With Treatment-emergent Adverse Events Associated With the MediBeacon Transdermal GFR Measurement System Device(From the time of dosing through the follow-up visit, up to 10 days)
- Number of Participants With Treatment-emergent Adverse Events Associated With MB-102 Administration(From the time of dosing through the follow-up visit, up to 10 days)