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 Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis (NCT03612856), a randomized phase 2 study. The primary outcome is The Number of Subjects With Treatment-related Adverse Events (TEAEs) and the Number of TEAEs Will be Summarized Using Frequency Counts (Safety and Tolerability).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03612856 |
| Phase | Phase 2 |
| Condition | End Stage Renal Disease, Thrombosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 27 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Aronora, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
People with end-stage renal disease who were receiving chronic hemodialysis. The registry describes the study population in those terms; further eligibility details and a more specific description of the analyzed population are not reported in the registry record.
Intervention
A single dose of xisomab 3G3, also called AB023, administered at the beginning of a regular hemodialysis procedure. The study included a dose of 0.25 mg/kg and a dose of 0.5 mg/kg.
Comparator
A single dose of placebo. The brief summary describes randomization to active treatment or placebo within each dose cohort at a 2:1 active-to-placebo ratio.
Primary question
Over 21 days, what frequency of treatment-related adverse events and affected participants was observed, as a measure of safety and tolerability? The stated primary outcome was to summarize the number of participants with treatment-related adverse events and the number of those events using frequency counts.
The study also registered pharmacodynamic outcomes related to hemodialysis efficiency, including filter and circuit clotting, blood urea nitrogen, KtV, potassium, and session length. It listed activated partial thromboplastin time as another pharmacodynamic outcome, and maximum plasma concentration and time to maximum concentration as pharmacokinetic outcomes. These outcomes broaden the questions beyond adverse events, but the posted primary result is a safety measure rather than a comparative efficacy estimate.
The registry identifies end-stage renal disease and thrombosis as conditions of interest. It does not report a separate primary efficacy question or a defined clinical threshold for judging a change in dialysis efficiency. The clinical question that can be addressed from the posted primary result is therefore narrow: what safety event counts were recorded in each study arm during the stated follow-up period?
3. Trial Design
This was a phase 2, randomized, parallel-group study of xisomab 3G3 and placebo in people with end-stage renal disease receiving chronic hemodialysis. The registry lists quadruple masking, while the official title describes the study as double-blind. The record does not explain the difference between those descriptions or identify which roles were masked.
The brief summary describes two dose cohorts, with participants in each cohort randomized to active treatment or placebo at a 2:1 active-to-placebo ratio. The intervention descriptions specify a single dose of 0.25 mg/kg for Dose 1 and a single dose of 0.5 mg/kg for Dose 2; the placebo arm received a single dose of placebo. Treatment was to be administered at the beginning of a regular hemodialysis procedure.
Registry enrollment was 27. The posted primary-outcome arm results list 8 participants in each of the two active-dose arms and 8 in the placebo arm. The registry record does not explain how these outcome counts relate to the enrollment figure, or whether any participants were excluded from these results.
The study started on 2018-10-29, had a primary completion date of 2019-07-06, and is listed as completed. The primary safety outcome had a timeframe of 21 days. The record lists 52 outcome measures and 15 posted secondary outcomes, but does not provide a statistical analysis record for the results. The number of analyses listed is 0. Details about the allocation sequence, concealment, stratification, dose-cohort assignment, or a prespecified statistical analysis plan are not reported in the registry record.
This design can describe outcomes in the randomized groups, but interpretation depends on the completeness and detail of the posted results. The small arm counts shown in the primary results and the absence of comparative estimates mean that the record does not establish how precisely any between-group difference has been estimated.
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: A total of 37 participants were screened for the study, of which 10 did not meet eligibility criteria. The remaining 27 participants were enrolled. 3 participants terminated the study prior to randomization either by withdrawing consent or at the PI's discretion. The remaining 24 participants were randomized into the study and dosed.
Pre-dose Period
| Stage | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| STARTED | 8 | 10 | 9 |
| COMPLETED | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 2 | 1 |
Reasons for not completing this period:
| Reason | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Physician Decision | 0 | 1 | 1 |
| Withdrawal by Subject | 0 | 1 | 0 |
Post-dose Period
| Stage | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| STARTED | 8 | 8 | 8 |
| COMPLETED | 8 | 8 | 8 |
| NOT COMPLETED | 0 | 0 | 0 |
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.
| Characteristic | Unit | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 8 | 8 | 8 | 24 | |
| Age, Continuous | years | 55.8 (SD 7.59) | 53.1 (SD 5.30) | 52.6 (SD 9.21) | 53.8 (SD 7.34) |
| Sex: Female, Male: Female | Participants | 1 | 3 | 1 | 5 |
| Sex: Female, Male: Male | Participants | 7 | 5 | 7 | 19 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 2 | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 8 | 8 | 6 | 22 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 8 | 7 | 6 | 21 |
| Race (NIH/OMB): White | Participants | 0 | 1 | 2 | 3 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 8 | 8 | 8 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as The Number of Subjects With Treatment-related Adverse Events (TEAEs) and the Number of TEAEs Will be Summarized Using Frequency Counts (Safety and Tolerability), measured over 21 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint concerns treatment-related adverse events and is explicitly framed as a safety and tolerability outcome. It was to count participants who experienced treatment-related adverse events and to count the events themselves. The stated timeframe is 21 days. The registry says that treatment-emergent adverse events were determined by physical examination, including assessment of the skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and musculoskeletal system.
Counting affected participants and counting events answer related but distinct descriptive questions. A participant count indicates how many people had an event, while an event count can reflect repeated events in a participant. Frequency counts are therefore a direct way to present the observed safety burden without assuming that events are continuous measurements. The registry does not provide definitions for event severity, relatedness assessment, or how repeated events were handled in the primary endpoint.
The primary results list a value of 0 participants for each arm. Separately, the harms results report other adverse events affecting 2 participants in the Dose 1 arm, 0 in the Dose 2 arm, and 1 in the placebo arm. These entries are not readily reconciled from the registry record. In particular, the record does not explain whether the primary outcome and harms entries use different definitions, populations, or reporting procedures. They should be read as separate posted records, not combined into a new endpoint estimate.
The endpoint is appropriate for describing reported safety events during the defined follow-up, but it does not by itself measure dialysis efficiency or establish a treatment effect on clinical outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry’s primary-outcome results report a value of 0 for each of the three arms, each of which lists 8 participants. The primary endpoint is described as the number of participants with treatment-related adverse events, with the number of events also to be summarized. The posted arm values therefore indicate no recorded primary-endpoint participants in those result entries. The registry does not provide a confidence interval, hypothesis test, or adjusted comparison for these counts.
The harms record separately reports no serious adverse events and no deaths in any arm. For other adverse events, it reports 2 affected participants in the Dose 1 arm, none in the Dose 2 arm, and 1 in the placebo arm. These results do not match the all-zero primary endpoint entries in an obvious way. The record does not explain the discrepancy in what appears to be captured or how the entries relate. The two parts of the record should not be treated as interchangeable or reconciled by assumption.
These are small descriptive counts. With 8 participants listed per arm, a zero count in a result entry is not proof that the underlying risk is zero or that an event could not occur in a broader population. In general, estimates based on few observations are imprecise, and absence of a reported event is different from evidence of absence. No interval estimate is posted to quantify that uncertainty.
The primary outcome is a safety measure, not a direct test of dialysis efficacy. Although the registry lists secondary outcomes involving clotting, blood urea nitrogen, KtV, potassium, dialysis duration, aPTT, and pharmacokinetic measures, the provided results do not include their numerical findings. The presence of an outcome in a registry does not establish that its result was reported or that it supports a particular interpretation.
The record reports enrollment of 27, while the primary results list 8 participants in each arm. The registry does not explain the difference. It also lists 15 secondary outcomes but 0 analyses, so the posted record offers little information about inferential comparisons, prespecified analysis choices, or handling of multiple outcomes. A comparative treatment effect cannot be inferred from the arm counts alone.
Accordingly, the posted data support only a cautious description of the recorded counts. They do not establish comparative safety, exclude uncommon harms, or establish an effect on dialysis performance. The discrepancy between primary-endpoint entries and other adverse-event entries, the small arm counts, and the lack of uncertainty estimates all limit the strength of any statistical conclusion.
9. Statistical Methods Explained
For a binary safety outcome, the basic descriptive result is the number of participants with an event in each arm. This endpoint is reported as a participant count, not as a continuous measurement with a mean and standard deviation. The primary outcome also refers to the number of events, which can differ from the number of participants if any participant experiences more than one event. The registry does not give a separate event total in the posted arm results.
What do frequency counts show?
Frequency counts describe what was recorded in the study groups. They are useful when the outcome is whether participants experienced an event, or how many events occurred. Counts alone do not quantify the uncertainty around the underlying event frequency. A confidence interval, in general, describes a range of values compatible with the data under a specified method; it is not reported for this primary result. A p-value, in general, addresses compatibility with a stated null hypothesis under an analysis model; no such test is reported for the primary endpoint.
The registry lists a value of 0 in each primary-outcome arm result, with 8 participants listed in each arm. These entries are descriptive, not a comparative statistical analysis. Without a reported interval or test, the precision of any contrast between groups is not quantified. With small counts, individual observations can have a substantial influence on a group’s summary, and a zero count should not be interpreted as a guarantee of zero risk.
What does randomization contribute?
In general, random allocation aims to make treatment groups comparable at the start of a trial with respect to both measured and unmeasured characteristics. This supports a causal comparison when assignment, follow-up, and analysis are conducted as planned. Randomization does not ensure that small groups will be balanced on every characteristic, and it does not resolve incomplete or unclear outcome reporting. The registry labels the study randomized, but details of the sequence generation and allocation concealment are not reported in the registry record.
The study is described as parallel-group, with two active dose arms and a placebo arm. The brief summary states that randomization occurred within each dose cohort and describes a 2:1 active-to-placebo ratio. The posted primary-outcome participant counts are 8 for each arm. The record does not clarify how the cohort structure, stated allocation ratio, and outcome counts correspond. No further allocation details should be inferred from these entries.
Why are confidence intervals and analysis details useful?
General statistical interpretation benefits from estimates of effect and their uncertainty. A confidence interval can show how broad the range of plausible effects is under the chosen method. For sparse binary outcomes, the method used to calculate an interval or test can matter, particularly when one or more groups have no events. The registry does not report an interval method, a treatment-effect estimate, a test, or a model for the primary safety comparison. Therefore, a recalculated comparison is not presented as a substitute for a sponsor analysis.
The registry reports 0 analyses. This does not mean that no analysis was conducted outside the registry; it means the record does not list analyses for the posted results. The statistical plan, including any covariate adjustment, analysis population, treatment of missing observations, or handling of repeated events, is not reported in the registry record. It would be inappropriate to assume an intention-to-treat analysis, a per-protocol analysis, or a particular model.
How should the sample-size illustrations be read?
General planning calculations can translate an assumed effect and chosen design assumptions into a hypothetical sample size. They are not descriptions of the observed trial and are not observed power. The sample-size assumptions attached to this analysis describe an illustration based on the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. For time-to-event outcomes, the stated convention is to report total events, while other outcomes are expressed as participants per arm.
Those assumptions are not evidence that the trial was designed using those values. The registry does not report its own sample-size justification, and no sample-size plan should be attributed to the investigators from a planning illustration. In general, planning around an observed effect can be unstable because the observed effect itself may be imprecise, especially in a small study. A planning result should therefore be interpreted as an illustration of assumptions, not as a claim that the completed study had adequate power or that an effect is established.
In general, over-dispersion matters when observed count variation exceeds what a chosen statistical model expects. A model that ignores extra variation can understate uncertainty. The primary endpoint is reported using frequency counts, and the registry record does not state that a count model was used or report a dispersion assessment. No conclusion about over-dispersion or model adequacy can be drawn from the posted counts alone.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| AB023 (Xisomab 3G3)- Dose 1 | 8 | 0 | 0.0% | 0.0% to 36.9% | 0.0% to 32.4% | 0.3% to 33.6% |
| AB023 (Xisomab 3G3)- Dose 2 | 8 | 0 | 0.0% | 0.0% to 36.9% | 0.0% to 32.4% | 0.3% to 33.6% |
| Placebo | 8 | 0 | 0.0% | 0.0% to 36.9% | 0.0% to 32.4% | 0.3% to 33.6% |
R code and output
arm <- c("AB023 (Xisomab 3G3)- Dose 1", "AB023 (Xisomab 3G3)- Dose 2", "Placebo")
n <- c(8, 8, 8)
events <- c(0, 0, 0)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM AB023 (Xisomab 3G3)- Dose 1 8 0 0.0 0.0 36.9 0.0 32.4 0.3 33.6
ARM AB023 (Xisomab 3G3)- Dose 2 8 0 0.0 0.0 36.9 0.0 32.4 0.3 33.6
ARM Placebo 8 0 0.0 0.0 36.9 0.0 32.4 0.3 33.611. Multiplicity, Missing Data and Analysis Populations
The registry lists 52 outcome measures and 15 posted secondary outcomes, alongside a primary safety endpoint. Testing or interpreting many outcomes can increase the chance of finding an apparently notable result by chance if no multiplicity strategy is specified. In general, multiplicity methods can control or describe that concern, but the appropriate approach depends on the prespecified questions and analysis plan. A multiplicity strategy is not reported in the registry record.
The registry lists 0 analyses. It does not report which outcomes were formally tested, whether secondary outcomes were exploratory, or whether any adjustment for multiple comparisons was planned. The secondary outcomes include several related measures of hemodialysis efficiency as well as pharmacodynamic and pharmacokinetic outcomes. Their listing does not establish that each was analyzed or that any particular result was statistically supported.
Missing-data handling and analysis populations are also not reported in the registry record. The results list 8 participants in each arm, while registry enrollment is 27; the record does not explain how these figures relate or whether any data were missing, excluded, or unavailable for particular outcomes. No assumptions about missingness, imputation, or participant disposition should be made.
In general, missing observations can affect both the estimated event frequency and the interpretation of comparisons, depending on why observations are absent and how they are handled. Without participant-flow details and a stated analysis population, the extent and consequences of missing data cannot be assessed. The registry also does not say whether all randomized participants were included in the primary analysis.
12. 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 |
|---|---|---|---|
| AB023 (Xisomab 3G3)- Dose 1 | 0 | 8 | 0.0% |
| AB023 (Xisomab 3G3)- Dose 2 | 0 | 8 | 0.0% |
| Placebo | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AB023 (Xisomab 3G3)- Dose 1 | 0 of 8 |
| AB023 (Xisomab 3G3)- Dose 2 | 0 of 8 |
| Placebo | 0 of 8 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| AB023 (Xisomab 3G3)- Dose 1 | 2 of 8 |
| AB023 (Xisomab 3G3)- Dose 2 | 0 of 8 |
| Placebo | 1 of 8 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|---|
| Viral gastroenteritis | Infections and infestations | 2 of 8 | 0 of 8 | 1 of 8 |
The serious adverse event figures are reported as 0 affected participants in the Dose 1 arm, 0 in the Dose 2 arm, and 0 in the placebo arm. Each harms group lists 8 participants at risk. The record also reports 0 deaths in each arm, and the serious adverse event terms list is empty. These are the serious-event and death entries recorded in the registry.
The other-adverse-event figures are distinct from the serious-event figures: 2 affected participants are listed for Dose 1, 0 for Dose 2, and 1 for placebo. The harms record does not provide event terms for those entries in the registry record for this analysis. The registry’s primary endpoint entries, by contrast, list a value of 0 in each arm. The record does not explain why those primary entries differ from the other-adverse-event counts.
In general, zero recorded serious events in a small study does not rule out uncommon harms. The counts describe observed reports in the listed groups during the recorded study, not the full range of possible risk. The registry record does not provide event-level narratives, severity details, timing, or a fuller account of relatedness assessments. The figures should therefore be interpreted as descriptive reporting, not as proof that serious adverse events cannot occur.
13. What the Result Does, and Does Not, Mean
The results have a limited descriptive meaning: the primary-outcome entries report a value of 0 for each arm, and the harms record reports no serious adverse events or deaths. It also records other adverse events affecting 2 participants in the Dose 1 group, none in the Dose 2 group, and 1 in the placebo group. These entries describe the events recorded in the registry, but the primary and harms sections are not reconciled in the record.
They do not establish that xisomab 3G3 is safer, less safe, or equivalent to placebo. No comparative effect estimate, confidence interval, or statistical test is reported for the primary endpoint. The posted group counts are small, and a zero entry does not show that the underlying event risk is zero. The registry also does not report a prespecified decision threshold for judging safety differences.
These primary results do not answer whether treatment affects hemodialysis efficiency. The registry lists outcomes concerning filter and circuit clotting, blood urea nitrogen, KtV, potassium, session length, aPTT, and pharmacokinetic measurements, but numerical results for those outcomes are not reported in the registry record summarized in the registry record. Outcome registration alone is not evidence of an effect or of a completed analysis.
The registry record also does not provide enough information to evaluate the trial’s own power or sample-size rationale. Any sample-size illustrations are planning exercises based on stated assumptions, not observed power and not proof that the study could reliably detect a particular effect. The results should therefore be understood as a small set of descriptive safety observations with important reporting and precision limitations.
General statistical interpretation distinguishes lack of evidence for a difference from evidence that groups are alike. The absence of a reported test or interval leaves the uncertainty around the group comparison unquantified. The posted counts should not be used to make clinical decisions or to infer treatment benefit.
14. Why This Trial Matters Statistically
This trial illustrates why the form of a reported outcome matters. The primary endpoint is based on participant and event frequency counts, while the registry also contains a separate harms record. The primary arm entries are all 0, but the harms record lists other adverse events affecting participants in two arms. Without a definition or explanation that reconciles the entries, readers cannot confidently treat them as different presentations of the same endpoint. Clear endpoint definitions and consistent reporting are essential for interpretable safety results.
The record also distinguishes registered outcomes from analyzed results. Many outcomes are listed, including measures of dialysis efficiency and pharmacology, but their presence does not show that results were analyzed or posted. The record lists 0 analyses. This makes it difficult to assess which questions were addressed, what comparisons were intended, or whether the reported results cover all planned outcomes.
Small group counts highlight the difference between observed frequency and precision. A zero event count may look definitive, but without an uncertainty interval it does not communicate how much uncertainty remains. General statistical practice emphasizes reporting effect estimates with uncertainty, along with clear denominators and an analysis population. Those details are important when results are sparse.
The trial is also a useful example of why registry design descriptions need careful reading. The record labels masking as quadruple, while the official title uses double-blind; it does not explain this difference. Enrollment and arm-result counts likewise are not reconciled. These details do not invalidate the posted findings, but they limit what can be inferred about how the study was conducted and analyzed.
For clinical researchers and biostatisticians, the statistical lesson is not to overread a count table. Interpretation depends on definitions, analysis populations, uncertainty, and a transparent relationship between the protocol and posted results. When those elements are not reported, the appropriate conclusion is bounded by the descriptive information available.
15. 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 primary-outcome record gives no confidence intervals, p-values, treatment-effect estimate, or stated model. As a result, the precision of the safety comparison cannot be assessed from the registry results. The primary arm values of 0 are also difficult to reconcile with the separate harms entries for other adverse events, which report affected participants in the Dose 1 and placebo groups. The registry record does not explain whether the outcome definitions or reporting populations differ.
Although enrollment is listed as 27, the primary results list 8 participants per arm. Participant flow and the relationship between these figures are not reported in the registry record. There is no information about withdrawals, exclusions, outcome-specific missingness, or the population included in the analysis. The record does not report a sample-size justification or establish that the study was sized to detect a particular safety difference.
The masking description is also not fully clear: the registry field identifies quadruple masking, while the official title describes the study as double-blind. The record does not clarify the roles masked or explain the differing descriptions. Further details about allocation generation and concealment are not reported.
The primary safety endpoint is framed around a 21-day timeframe, and the registry describes physical examination assessments. Event definitions, severity categories, relatedness procedures, and handling of multiple events per participant are not detailed in the record. The listed secondary outcomes have no numerical results in the registry record used for this analysis, and no analysis details are reported.
These limitations constrain interpretation to the posted descriptive entries. They do not establish that unreported analyses were not conducted, but the analyses and methods are not reported in the registry record.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis — NCT03612856.
- Registry record last updated 2024-03-07; status last verified 2024-03.
- Results first posted 2020-07-22.
- 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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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
19. Record Summary
NCT03612856 is a completed phase 2 randomized, parallel-group study of AB023, also called xisomab 3G3, in people with end-stage renal disease receiving chronic hemodialysis. The study included a single 0.25 mg/kg dose, a single 0.5 mg/kg dose, and placebo. The registry lists enrollment of 27 and a primary safety-outcome timeframe of 21 days.
The primary endpoint concerns counts of participants with treatment-related adverse events and counts of events. The primary result entries list 0 for each arm, with 8 participants listed per arm. Separately, the harms record lists no serious adverse events or deaths and reports other adverse events affecting 2 participants in Dose 1, none in Dose 2, and 1 in placebo. The registry does not explain the difference between the primary and harms entries.
The record lists 52 outcome measures, 15 posted secondary outcomes, and 0 analyses. Comparative estimates, uncertainty intervals, analysis populations, missing-data methods, and the trial’s sample-size justification are not reported in the registry record.