This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring (NCT05777174), a non-randomized phase 3 study. The primary outcome is Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05777174 |
| Phase | Phase 3 |
| Condition | Kidney Diseases, Kidney Injury, Kidney Failure |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 149 |
| Arms in the primary outcome | n/a |
| Lead sponsor | MediBeacon |
| Results posted | Yes |
2. Clinical Question
Population
Adults with kidney function spanning the range described as eGFR <120 to >15 mL/min/1.73 m2, and spanning the human skin-color range defined by the Fitzpatrick Skin Scale. The registry describes groups with eGFR ≥ 70 mL/min/1.73 m^2 and eGFR < 70 mL/min/1.73 m^2.
Intervention
A single dose of MB-102 (relmapirazin), with transdermal fluorescence measured using the MediBeacon Transdermal GFR Measurement System and TGFR reusable sensor with disposable adhesive ring.
Comparator
Transdermal-derived GFR (tGFR) was compared with plasma-derived indexed GFR (nGFR), measured using MB-102. This is a comparison of measurement methods, not a randomized comparison of treatments.
Primary question
What proportion of tGFR values were within 30% of nGFR, and did the lower limit of the double-sided 97% confidence interval exceed the performance goal of 0.85?
The study asks whether a non-invasive transdermal measurement can provide GFR values that are sufficiently close to the plasma-derived measurement under the endpoint's stated criterion. The primary outcome is the proportion of transdermal-derived values within 30% of the measured plasma-derived indexed values, called P30 in the registry description. The comparison was planned across participants in the modified intent-to-measure population, defined as enrolled participants with an average session tGFR or average snapshot tGFR calculated, no major protocol deviations, and no outlier pharmacokinetic parameters.
The registry also describes safety and effectiveness evaluation for the device and secondary outcomes counting participants with treatment-emergent adverse events associated with MB-102 administration or the measurement system. The record does not report a primary endpoint estimate or confidence interval. Therefore, the stated question and success rule can be described, but whether the criterion was met cannot be determined from the reported endpoint information.
3. Trial Design
This was a completed Phase 3, open-label, multicenter, non-randomized, parallel study sponsored by MediBeacon. The registry lists enrollment of 149. Its stated purpose was to compare tGFR measured with the MediBeacon Transdermal GFR System using MB-102 with plasma-derived indexed GFR, and to evaluate safety and effectiveness of the system and sensor arrangement.
The trial included adults across the kidney-function range described as eGFR <120 to >15 mL/min/1.73 m2, including people with different levels of renal compromise. The summary also says the study spanned the human skin-color range as defined by the Fitzpatrick Skin Scale. The arm descriptions divide participants into eGFR ≥ 70 mL/min/1.73 m^2 and eGFR < 70 mL/min/1.73 m^2 groups. These are enrollment groups, not randomized treatment arms.
On the dosing day, the sensor was placed on the participant's chest and the system collected background fluorescence before MB-102 was administered. The arm descriptions state that sensor placement occurred at least 15 minutes before dosing. Blood samples and fluorescence measurements were collected over 12- or 24-hour periods, or longer, depending on enrollment group. For participants with significant renal compromise, measurements continued until the sensor no longer detected MB-102 in the body.
Because allocation was non-randomized and there was no masking, the design does not support interpreting the eGFR groups as like-for-like randomized controls. The central comparison is between measurement approaches within the study, rather than between assigned therapies. Further details about allocation procedures, the protocol's sample-size justification, and any interim analyses are not reported in the registry record. The listed study dates are 2023-03-20 for start and 2024-04-15 for primary completion.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Safety Population: all participants who enrolled in the study and were dosed with MB-102
Overall Study
| Stage | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|
| STARTED | 84 | 65 |
| COMPLETED | 84 | 65 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Modified intent-to-measure population (all participants enrolled in the study for whom an average session tGFR or an average snapshot tGFR had been calculated, with no major protocol deviations and no outlier pharmacokinetic parameters)
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Population: all participants who enrolled in the study and were dosed with MB-102
| Characteristic | Unit | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 | Total |
|---|---|---|---|---|
| Participants analysed | 84 | 65 | 149 | |
| Age, Continuous | years | 51.5 (SD 12.9) | 66.0 (SD 8.62) | 57.8 (SD 13.3) |
| Sex: Female, Male: Female | Participants | 37 | 33 | 70 |
| Sex: Female, Male: Male | Participants | 47 | 32 | 79 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 34 | 26 | 60 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 50 | 39 | 89 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 2 | 0 | 2 |
| Race/Ethnicity, Customized: Asian | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: Black or African American | Participants | 26 | 31 | 57 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: White | Participants | 52 | 30 | 82 |
| Race/Ethnicity, Customized: Other | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: Unknown or not reported | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Correlation of Transdermal Derived Glomerular Filtration Rate (tGFR) to the Plasma-derived Indexed Glomerular Filtration Rate (nGFR), measured over Up to 24 hours following the study dose.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 97% Confidence Interval |
| Unit | Proportion of tGFR within 30% of nGFR |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the proportion of transdermal-derived GFR values within 30% of the measured plasma-derived indexed GFR. This proportion is described as P30. It summarizes how often the transdermal measurement falls within the registry's stated tolerance relative to the plasma-derived measurement across the assessed participants. The endpoint is not a mean difference, and it does not describe how far apart measurements are when they fall outside that tolerance.
The registry specifies a double-sided 97% confidence interval for the comparison and sets the performance goal at 0.85. The study's success rule is that the lower limit of this interval must be greater than 0.85. This rule asks whether the data support a P30 proportion above the prespecified performance goal with the stated level of interval confidence, rather than relying on the point estimate alone.
Agreement-style criteria can be useful when the question is whether a new measurement method produces values close enough to a reference measurement for the intended evaluation. P30 reduces each tGFR-to-nGFR comparison to whether it lies within or outside the defined range. That makes the endpoint interpretable as a proportion, but it also discards information about the direction and size of discrepancies beyond the cutoff. The registry record gives the endpoint definition and rule but does not report the observed P30 estimate or its confidence limits. Thus, the endpoint's performance cannot be assessed from the result information recorded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted record identifies a clear primary performance measure: the proportion of tGFR values within 30% of nGFR. It also states how success was to be judged: the lower limit of a double-sided 97% confidence interval had to be greater than 0.85. This specifies an intended decision rule, but it is not itself evidence that the rule was satisfied.
The registry record does not report the observed P30 proportion, the lower or upper confidence limit, or an analysis result for the primary endpoint. Consequently, the posted information does not show whether the point estimate was above the performance goal, how much uncertainty surrounded it, or whether the lower confidence limit cleared the required threshold. Without those results, neither success nor failure against the stated criterion can be concluded from this record.
The distinction between an estimate and its confidence interval matters. The point estimate summarizes the observed proportion in the analysis population. The interval communicates uncertainty around that estimate under the analysis method. The decision rule uses the lower limit, so knowing only a point estimate would not be enough to verify the registry's stated definition of success. Conversely, the criterion alone cannot substitute for the missing estimate and interval.
The analysis population is described as modified intent-to-measure. It includes enrolled participants for whom an average session tGFR or average snapshot tGFR was calculated, with no major protocol deviations and no outlier pharmacokinetic parameters. This definition indicates that the primary analysis was not simply described as including every enrolled participant. The registry does not report the number included in this population, the number excluded, or the reasons for individual exclusions. The extent to which this population differed from all enrolled participants therefore cannot be assessed from the posted information.
The study was non-randomized, open-label, and organized by eGFR groups. Those design features do not invalidate a comparison of two measurement methods, but they do limit what can be inferred about treatment effects or between-group causal contrasts. The result should be understood as a planned assessment of measurement performance in the studied participants, not as evidence from a randomized treatment comparison. The registry record does not provide subgroup endpoint estimates, so performance across eGFR groups or skin-color categories cannot be evaluated separately from the information.
The adverse-event summary lists no serious adverse events among the participants at risk in either eGFR group, and no deaths. It also lists other adverse events, but these counts do not answer the primary measurement-performance question. The absence of reported serious events in this summary should be read as a descriptive finding for the recorded groups, not as a complete characterization of safety beyond the registry's listed outcomes and reporting period.
Overall, the record gives the study design, endpoint definition, success threshold, and some adverse-event counts. It does not provide the primary endpoint results or detailed analysis outputs. Any broader conclusion about measurement performance, precision, subgroup consistency, or the success criterion would go beyond what the posted results show.
9. Statistical Methods Explained
The primary endpoint combines a proportion with an uncertainty interval and a threshold-based success rule. These elements answer related but distinct questions: the proportion describes observed agreement according to a defined tolerance, the interval describes uncertainty around that estimate, and the threshold sets the criterion the study intended to use for success.
What P30 represents
For this endpoint, each relevant tGFR value is judged against its corresponding measured nGFR value. A value counts as within the endpoint's tolerance if it is within 30% of nGFR. P30 is the proportion of values meeting that condition across the participants described in the endpoint definition. The measure is therefore a summary of how frequently the specified closeness criterion was met, rather than a summary of average signed error.
This type of proportion is easy to interpret, but it compresses information. Values just inside and farther inside the tolerance contribute in the same way to the proportion. Values outside the tolerance also contribute alike to the classification even if their deviations differ in size or direction. Other summaries could describe those features, but the registry record does not state additional primary measurement summaries.
Why use a confidence interval
A confidence interval expresses the uncertainty associated with an estimate under the statistical method used. General interpretation: a narrower interval indicates greater precision, while a wider interval indicates less precision. The interval is not a range that guarantees the true value lies within it, nor does the stated confidence level tell us the probability that a particular fixed value is true after the data have been observed.
The registry specifies a double-sided 97% confidence interval for P30. The study's success rule focuses on the lower limit: it must be greater than 0.85. In general, using a lower confidence limit for a performance threshold requires the data to support not just a favorable point estimate but also a sufficiently high lower bound. The record does not report the estimate or either confidence limit, so the rule cannot be checked from the result information.
Why the analysis population matters
The primary endpoint population is described as modified intent-to-measure. It consists of enrolled participants with an average session tGFR or average snapshot tGFR calculated, no major protocol deviations, and no outlier pharmacokinetic parameters. Excluding participants for missing or unusable measurements, protocol deviations, or pharmacokinetic criteria can change the population represented by the estimate. That is why the number analyzed and the handling of excluded or incomplete measurements are important for interpretation.
The registry does not report the size of the modified intent-to-measure population, the number of participants excluded from it, or the detailed methods used to address missing measurements. It also does not describe sensitivity analyses showing how conclusions might change under other population definitions. These details are not reported in the registry record, so the robustness of the primary endpoint to exclusions or incomplete data cannot be evaluated.
What the design can establish
General explanation: a non-randomized study does not assign participants at random to competing treatments, so it should not be interpreted as a randomized treatment comparison. Here, the stated question concerns agreement between tGFR and nGFR measurements after MB-102 administration. The groups defined by eGFR describe participant categories; they are not identified as randomized control groups. Results, if reported, would need to be interpreted in the context of the study's enrolled population, measurement procedures, and analysis population.
Open-label status means masking was not used according to the registry listing. For an instrument-based fluorescence measurement, the implications depend on how measurements were collected, processed, and analyzed. The record does not provide enough detail to characterize those procedures or the influence of unmasked study conduct. It is therefore not appropriate to infer either the presence or absence of bias from the masking field alone.
Over-dispersion and count outcomes
General explanation: over-dispersion occurs when count data vary more than a statistical model expects. If present and not accounted for, it can make standard errors too small and confidence intervals too narrow. The registry's listed secondary outcomes count participants with treatment-emergent adverse events. However, the posted information does not describe a model for these counts, report an over-dispersion assessment, or provide inferential comparisons. It would be speculative to say that a particular count model or adjustment was used.
The record lists no analysis entries for the outcomes. Specific inferential methods, any covariate adjustments, and any procedures for handling repeated or correlated measurements are not reported in the registry record. General statistical explanations can clarify how such methods would work, but they cannot establish which methods were actually used in this study.
Planning illustrations are not trial results
Sample-size illustrations shown elsewhere on the page are planning calculations, not observed power and not evidence that an endpoint result was achieved. General explanation: a planning calculation depends on assumptions about the effect to detect, variability, significance level, allocation, and statistical approximation. The accompanying assumptions describe illustrations based on a fraction of the observed effect, two-sided significance level 0.05, equal allocation, and a normal approximation. They are not the trial's own design justification. The trial's sample-size justification is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and two secondary safety outcomes: the number of participants with treatment-emergent adverse events associated with MB-102 administration, and the number with treatment-emergent adverse events associated with the MediBeacon Transdermal GFR Measurement System device. The primary endpoint has a stated confidence-interval-based success rule. The record does not describe a multiplicity procedure for interpreting the primary and secondary outcomes together, nor does it report whether any adjustment was planned or applied. That information is not reported in the registry record.
Multiplicity matters when several outcomes or comparisons are used to make inferential claims, because the chance of at least one apparently notable result can rise as more tests are considered. General explanation: prespecifying a primary endpoint and a decision rule helps clarify which result is central, but it does not by itself tell us how other tests were handled. Since no analysis entries are listed, the registry information does not establish whether secondary outcomes were analyzed descriptively only or whether formal tests were conducted.
Missing-data handling is also not described. The primary population requires a calculated average session tGFR or average snapshot tGFR and excludes major protocol deviations and outlier pharmacokinetic parameters. The record does not state how unavailable measurements were handled, how many participants lacked a usable endpoint, or whether any imputation or sensitivity analysis was used. These details are not reported in the registry record.
The modified intent-to-measure definition is relevant because it sets conditions for inclusion in the primary analysis. Without its final population count and an account of exclusions, it is not possible to assess how closely the analyzed group reflects all enrolled participants. The protocol's interim-analysis plan, if any, is also not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | 0 | 84 | 0.0% |
| Participants With eGFR < 70 mL/Min/1.73 m^2 | 0 | 65 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | 0 of 84 |
| Participants With eGFR < 70 mL/Min/1.73 m^2 | 0 of 65 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | 2 of 84 |
| Participants With eGFR < 70 mL/Min/1.73 m^2 | 5 of 65 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Participants With eGFR ≥ 70 mL/Min/1.73 m^2 | Participants With eGFR < 70 mL/Min/1.73 m^2 |
|---|---|---|---|
| HYPERTENSION | Vascular disorders | 0 of 84 | 3 of 65 |
| INJECTION SITE EXTRAVASATION | General disorders | 0 of 84 | 2 of 65 |
| HEADACHE | Nervous system disorders | 2 of 84 | 0 of 65 |
The adverse-event summary separates participants with eGFR ≥ 70 mL/min/1.73 m^2 from those with eGFR < 70 mL/min/1.73 m^2. In the higher-eGFR group, 84 participants were listed as at risk for serious adverse events and 0 as affected. In the lower-eGFR group, 65 were listed as at risk and 0 as affected. The summary also lists 0 deaths in each group.
For the other-adverse-event category, the registry lists 2 affected participants among 84 at risk in the higher-eGFR group and 5 among 65 at risk in the lower-eGFR group. These are descriptive counts in the adverse-event summary. The record does not provide event terms for serious events, since none are listed, and the top serious terms list is empty. It does not report the timing, duration, severity, or detailed nature of the other events in the information.
These figures should not be treated as a randomized comparison between eGFR groups: allocation was non-randomized, and the groups reflect kidney-function categories. Nor should the counts be interpreted as a complete account of safety beyond the events and reporting represented in the registry. The listed secondary outcomes concern treatment-emergent events associated with MB-102 or the device, but the summary counts alone do not establish causation or distinguish the relative contribution of the drug, device, underlying condition, or other factors.
12. What the Result Does, and Does Not, Mean
The endpoint is designed to summarize how often transdermal-derived GFR measurements fall within the registry's specified 30% tolerance of plasma-derived indexed GFR. The accompanying success rule requires the lower limit of a double-sided 97% confidence interval to exceed 0.85. These definitions make the intended statistical question clear and provide a threshold for judging performance.
However, the registry record does not report the endpoint estimate or confidence interval. The posted information therefore does not establish whether the observed proportion met the threshold, how precise the estimate was, or whether the lower limit cleared the stated goal. A reader cannot infer those results from the study's completion status, design, enrollment, or endpoint definition.
Even if an endpoint result were available, it would describe performance in the analyzed participants and under the measurement and analysis procedures used in the study. It would not, on its own, show that every reading is close to the plasma-derived value, since P30 is a proportion and does not characterize the size or direction of deviations outside its tolerance. It would also not establish performance in populations or settings not described by the study.
The non-randomized design supports a measurement-method comparison, not a causal conclusion about treatment assignment. The eGFR groups are not like-for-like randomized controls. The summary describes inclusion across a range of kidney function and skin colors, but the posted endpoint information does not show separate results for those characteristics. It is not possible to determine from this record whether performance was consistent across such subgroups.
The safety counts are likewise descriptive. No serious adverse events or deaths are listed in the two eGFR groups, while other adverse events are recorded. Those figures do not replace detailed safety results and do not establish that an event was caused by MB-102 or the device. The registry provides neither the primary statistical result nor enough detail to make broader claims about precision, generalizability, subgroup performance, or the completeness of safety ascertainment.
13. Why This Trial Matters Statistically
This study addresses a statistical question that differs from a conventional treatment-versus-control question. Its central aim is to compare a transdermal measurement with a plasma-derived measurement of GFR after administration of MB-102. The relevant issue is how closely the measurements agree under a defined criterion, rather than whether one assigned treatment changes a clinical outcome relative to another.
The P30 endpoint makes that question concrete by summarizing the proportion of tGFR values within 30% of nGFR. The stated 0.85 performance goal and lower-confidence-limit rule distinguish a threshold-based assessment from a simple report of a point estimate. In general, this illustrates why an endpoint's decision rule and uncertainty measure matter together: a point estimate alone may not answer whether a prespecified performance standard was met.
The study also illustrates why reporting the analysis population is important. The modified intent-to-measure population has explicit eligibility conditions for the primary analysis, including the availability of a calculated tGFR and the absence of specified deviations or outlier pharmacokinetic parameters. Readers need the resulting population size and a clear account of exclusions to understand what group the endpoint represents. Those details are not reported in the registry record.
Finally, the record demonstrates the difference between a clearly described statistical target and a reported statistical result. The endpoint definition, confidence level, and success criterion are available, but the estimated proportion and confidence limits are not. The design and adverse-event counts provide context, but cannot fill that gap. For researchers, the key lesson is that interpretability depends not only on prespecification, but also on posting the estimate, its uncertainty, and the analysis details needed to evaluate it.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpretation is that the registry record does not report the primary P30 estimate or its double-sided 97% confidence interval. As a result, the stated success rule cannot be evaluated. The record lists no analysis entries, and does not provide a separate endpoint result in the information.
The modified intent-to-measure population is defined, but its final size is not reported. The numbers of participants excluded from the primary analysis, the reasons for exclusion, and the treatment of missing or unusable measurements are also not reported in the registry record. This prevents assessment of how analysis exclusions may have influenced the endpoint or how representative the analyzed population was of all enrolled participants.
The design was open-label and non-randomized, with parallel eGFR groups. Those groups should not be interpreted as randomized controls, and the available information does not support causal comparisons between them. Although the study summary describes a range of kidney function and skin colors, separate endpoint estimates by eGFR category or skin-color group are not reported. The consistency of measurement performance across those characteristics therefore cannot be judged from the posted endpoint information.
Further analysis details are not reported, including the specific statistical method used to form the confidence interval, any adjustment or covariate strategy, any sensitivity analysis, and the handling of multiplicity across outcomes. The protocol's sample-size justification and any interim-analysis plan are also not reported. The adverse-event summary gives participant counts but not detailed event descriptions or enough information to interpret the full safety profile. These gaps limit assessment of precision, robustness, and scope of inference.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of MB-102 (Relmapirazin) and the Use of the MediBeacon® Transdermal GFR Measurement System Using the TGFR Reusable Sensor With Disposable Adhesive Ring — NCT05777174.
- Registry record last updated 2025-03-28; status last verified 2025-03.
- Results first posted 2025-03-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes NCT05777174 as a completed Phase 3, open-label, multicenter, non-randomized, parallel study sponsored by MediBeacon, with enrollment of 149. It evaluated MB-102 (relmapirazin) alongside the MediBeacon Transdermal GFR Measurement System using the TGFR reusable sensor with disposable adhesive ring. The study compared tGFR with plasma-derived indexed GFR and included participants across the stated range of kidney function and skin colors.
The primary endpoint was the proportion of tGFR values within 30% of nGFR, with a double-sided 97% confidence interval and a performance goal of 0.85. Success required the lower confidence limit to be greater than 0.85. The endpoint estimate and confidence limits are not reported in the registry record, so the success criterion cannot be assessed from the posted results.
The adverse-event summary lists no serious adverse events or deaths in either eGFR group and lists other adverse events in both groups. Details about the primary analysis result, missing-data handling, multiplicity, and sample-size justification are not reported in the registry record.