Triferic AVNU Infusion Via Freedom Pump During Hemodialysis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Triferic AVNU Infusion Via Freedom Pump During Hemodialysis (NCT04689932), a na phase 4 study. The primary outcome is Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer.

2. Clinical Question

3. Trial Design

This is a phase 4 study recorded as completed, with an enrollment of 12. The registry lists a sequential study model, allocation as NA, and no masking. Its stated purpose is to evaluate intravenous delivery of Triferic AVNU using the Freedom Pump-20 during hemodialysis into pre-dialyzer and post-dialyzer blood lines. These design details indicate that the focus is infusion delivery in the dialysis circuit, rather than a randomized comparison against a control treatment.

The record describes pre-dialyzer infusion on study days 1, 3, and 5. The dose is stated as 6.75 mg Fe/4.5 mL, delivered through the Freedom Pump-20 during hemodialysis. It also lists a post-dialyzer infusion condition, with infusion position changing across study days; the post-dialyzer arm description is truncated in the registry record, so its full schedule cannot be established from that description alone. The study began on 2021-04-19, and primary completion is recorded as 2021-06-19.

The primary outcome is the time to complete the 4.5 mL pre-dialyzer infusion, summarized as a mean with standard deviation. The stated timeframe is days 1, 3, and 5, up to 3 hours. The registry also names mean maximum TSAT before and after the dialyzer as secondary outcomes, but their results are not reported in the registry record. Although the study status is completed, completion status does not itself establish that outcome estimates or an analysis plan are available in the record. No randomization scheme, masking procedure, or control group is described.

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.

Overall Study

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.

6. Primary Endpoint

The registry lists the primary outcome as Time for Complete Infusion of 4.5 mL Triferic AVNU Pre-Dialyzer, measured over On Days 1, 3, and 5, up to 3 hours.

The primary endpoint is the time, in hours, required to complete a 4.5 mL Triferic AVNU infusion into the pre-dialyzer blood line. It is intended to characterize delivery through the Freedom Pump-20 and flow-restrictor tubing while connected to the dialysis blood circuit. The record notes that the pump and tubing have a nominal flow rate of 2 mL/hour, but that administration time can vary with pressure in the dialyzer blood lines. That makes the observed completion time a practical measure of delivery under the circuit conditions of hemodialysis, rather than a measure of a clinical outcome.

The registry gives a target administration rate corresponding to 2.25 hours for a 4.5 mL volume and notes that product labeling advises administration over 3 to 4 hours. These are contextual reference points in the outcome description; they are not reported study results. The endpoint timeframe is days 1, 3, and 5, up to 3 hours. The registry specifies that the outcome is a mean with standard deviation, but reports neither the mean nor the standard deviation. It also does not report individual infusion times, a confidence interval, or a statistical test. Consequently, the record identifies what was meant to be measured and why it is relevant to delivery, but does not show the observed endpoint result or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The endpoint is a continuous measurement: time to complete infusion, expressed in hours. The registry specifies a mean and standard deviation as the summary statistics. In general, a mean describes the central level of a set of measurements, while a standard deviation describes how spread out those measurements are around the mean. They answer different questions: the mean concerns the typical measured time, whereas the standard deviation concerns variation among measured times. The registry does not report either statistic for the primary outcome, so neither the central estimate nor its observed variability can be assessed.

What does a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity under a stated statistical procedure. A narrow interval indicates greater precision than a wide interval, while an interval’s location indicates which values remain compatible with the data and method. The registry record does not report a confidence interval for the primary endpoint. Without an estimate and interval, readers cannot judge the precision of the infusion-time result or distinguish a precise estimate from an uncertain one.

What does the sequential design mean for comparisons?

The study model is recorded as sequential, and allocation is recorded as NA. The registry cautions that the study is not a randomized comparison and that the arms are not a like-for-like control comparison. In general, random allocation can help make comparison groups similar with respect to both measured and unmeasured characteristics. Without that design feature, observed differences between conditions may reflect the infusion position, the order in which conditions occurred, or other influences. The registry record does not report a statistical method for separating these possibilities.

The arm description identifies pre-dialyzer delivery on days 1, 3, and 5 and a post-dialyzer infusion condition on other study days, although the latter description is incomplete. A sequence of measurements can involve dependence among observations from the same participant. In general, analyses that ignore such dependence may misstate uncertainty. The record does not report whether measurements were analyzed as independent, paired, or repeated observations, nor does it describe any method for accounting for the sequence or within-participant correlation.

How should the pump-rate context be read?

The endpoint description gives a nominal pump and tubing flow rate of 2 mL/hour, says blood-line pressure can change administration time, and states a target administration time of 2.25 hours for 4.5 mL. It also notes product labeling that advises administration over 3 to 4 hours. These values provide context for the measurement; they are not estimates of the study’s observed mean. In general, a nominal flow rate does not guarantee a particular completion time when the connected system’s operating conditions can affect flow. The recorded endpoint is intended to measure the resulting completion time in the circuit.

What can be inferred from the analysis information?

The registry identifies the primary summary as a mean with standard deviation, but does not report the statistical test, confidence-interval method, model, or adjustment strategy. The number of analyses is listed as 0. These entries do not reveal how the outcome was analyzed or whether any planned analyses were conducted. The registry record also does not report an interim-analysis plan or a sample-size justification. Such details should not be inferred from the enrollment or from the study’s completed status.

The record describes a sample-size illustration as a planning calculation using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. It explicitly distinguishes that illustration from the trial’s own design. In general, a planning illustration estimates the number of participants that might be needed under its assumptions; it is not observed power and does not demonstrate that a study had a particular probability of detecting an effect. The registry entries do not report the numerical illustration or a primary-outcome estimate from which the stated effect could be checked.

Over-dispersion is a concern mainly for outcomes whose variability exceeds what a simple model assumes, such as some count outcomes. In general, a model that ignores excess variability can produce uncertainty estimates that are too small. The listed primary endpoint is continuous time, so the record does not establish that over-dispersion was present or that a count-data model was used. More broadly, selecting an analysis requires information about the distribution of the measurements and the design structure; those details are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Pre- Dialyzer Infusion and Post- Dialyzer Infusion")
n   <- c(12)
m   <- c(1.7)
sp  <- c(2)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Pre- Dialyzer Infusion and Post- Dialyzer Infusion  12  1.700  2.000  0.429  2.971

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 4 outcome measures and names two secondary outcomes: mean maximum TSAT before the dialyzer and mean maximum TSAT after the dialyzer. It does not report numerical results for these outcomes or explain how multiple outcomes were handled. A multiplicity strategy—such as defining which outcome is primary for inference or adjusting interpretation when several hypotheses are tested—is not reported in the registry record. The number of analyses is listed as 0, but the record does not explain that entry or provide a statistical analysis plan. No multiplicity adjustment should be assumed.

Missing-data handling is not reported in the registry record. The record does not say whether any infusion-time measurements or TSAT measurements were missing, how missing observations were treated, or whether an analysis included all enrolled participants or only those with recorded measurements. It also does not describe exclusions or reasons for any unavailable observations. Without that information, readers cannot assess whether the available measurements represent the intended study population or whether missingness could affect the reported summaries.

Analysis populations are not described. The registry does not identify a primary-outcome population, a safety population definition, or a rule for including measurements across study days. It also does not report whether repeated measurements were combined or analyzed separately. These omissions matter because the relevant denominator and the handling of incomplete sequences can affect how a mean and its uncertainty should be interpreted. The stated enrollment alone does not establish the number of participants contributing to any endpoint.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry lists 12 participants at risk in the pre-dialyzer infusion group and 12 in the post-dialyzer infusion group. It reports 0 serious adverse events and 0 other adverse events for each group, with 0 deaths in each. These are the event counts recorded for the listed groups; they should not be read as a complete description of all possible safety outcomes.

Zero recorded events does not establish that no events occurred outside the registry’s definitions, collection procedures, or reporting period. The record does not provide detailed adverse-event definitions, individual event descriptions, follow-up duration for safety, or an account of how events were solicited and assessed. It also does not explain whether the same participants contributed to both infusion conditions. The group entries therefore should not be combined into a total or treated as an independent comparison.

These figures are descriptive. The record does not report a comparative safety analysis, uncertainty interval, or test of differences between conditions. The small listed enrollment and lack of detailed safety methods mean the event counts alone cannot characterize the frequency of uncommon events or establish equivalence between infusion positions.

13. What the Result Does, and Does Not, Mean

The record identifies a practical delivery question: how long the pump-and-tubing system takes to complete a pre-dialyzer Triferic AVNU infusion during hemodialysis. It describes the measurement conditions, the intended time frame, and contextual pump and labeling information. Those details clarify the endpoint’s purpose, but the registry does not report the observed mean completion time, its standard deviation, or an interval expressing uncertainty. A numerical conclusion about the infusion time is therefore not supported by the registry record.

The study also identifies pre-dialyzer and post-dialyzer infusion conditions and names maximum TSAT before and after the dialyzer as secondary outcomes. No numerical results for those secondary outcomes are reported. In addition, the study is sequential rather than randomized, and the registry cautions that the conditions are not a like-for-like control comparison. Any observed difference, if reported elsewhere, would need to be interpreted in relation to that design rather than as a randomized treatment effect.

The zero event counts listed for serious adverse events, other adverse events, and deaths describe the registry entries for the two groups. They do not provide detailed event ascertainment or establish that the conditions have equivalent safety. The record’s limitations in reported outcomes and methods also prevent assessment of missing data, analysis populations, or statistical uncertainty.

Accordingly, the registry record supports a description of what the study set out to measure and how it was organized. It does not, by itself, establish the observed completion time, the precision of that estimate, the comparative effect of infusion position, or a broader clinical benefit or risk. Those conclusions would require outcome estimates and methods that are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically interesting because its primary outcome is a process measure shaped by the delivery system and the dialysis circuit. The registry explicitly notes that blood-line pressure can change administration time. That makes the measured time relevant to understanding delivery under the stated conditions, while also meaning that a nominal pump flow rate should not be treated as a guarantee of actual completion time. The distinction between a target, a nominal rate, and a measured outcome is important when interpreting device-related endpoints.

The sequential structure also illustrates why study design affects the meaning of a comparison. The record does not describe randomized allocation and warns that the infusion conditions are not a like-for-like control comparison. If estimates were available, the order of conditions and any repeated observations could matter for interpretation and uncertainty. The registry does not report how these design features were handled analytically, so a reader cannot determine whether the analysis accounted for them.

The record also demonstrates the difference between a study being marked completed and its numerical findings being available. Completion status and enrollment are not substitutes for outcome estimates, variability, confidence intervals, or a documented analysis. Without those quantities, statistical precision cannot be judged and the primary question cannot be answered from the registry record alone. The listed safety counts likewise need context about event definitions and observation procedures.

Finally, a planning illustration is distinct from a trial’s design justification or its observed findings. The record describes assumptions for an illustration based on the observed effect, but does not report a numerical primary result or the illustration’s numerical output. Keeping planning calculations separate from observed evidence prevents a hypothetical sample-size scenario from being mistaken for a result of this study.

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 principal limitation of the registry record for statistical interpretation is that it does not report the primary endpoint estimate. The mean time to complete the pre-dialyzer infusion and its standard deviation are absent, as are a confidence interval and a p-value. Results for the named secondary outcomes are also not reported. Consequently, the study’s observed delivery times, variability, and precision cannot be evaluated from the record.

The design is described as sequential, with allocation listed as NA and no masking. The registry explicitly warns that the infusion conditions are not a like-for-like control comparison. The post-dialyzer arm description is incomplete, and the record does not explain how measurements across study days were analyzed. It is therefore not possible to assess whether sequence effects or dependence among repeated observations were considered.

The registry does not report the analysis populations, missing-data procedures, statistical tests, confidence-interval methods, or multiplicity strategy. It also does not provide a sample-size justification or explain the listed analysis count. The stated planning illustration is not the trial’s own design, and its numerical results are not reported in the registry entries. The listed enrollment does not establish how many participants contributed to each outcome.

Safety reporting is also limited to group-level counts of serious adverse events, other adverse events, and deaths. Definitions, follow-up details, and event-collection methods are not reported. These limitations are specific to what the registry record makes available; they do not establish what may have been recorded or analyzed outside that record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Triferic AVNU Infusion Via Freedom Pump During Hemodialysis — NCT04689932.
• Registry record last updated 2022-02-28; status last verified 2022-02.
• Results first posted 2022-01-18.
• 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.

19. Record Summary

NCT04689932 is a completed phase 4, sequential study of Triferic AVNU delivered through the Freedom Pump-20 during hemodialysis. The registry lists enrollment of 12 and describes pre-dialyzer and post-dialyzer infusion conditions. The primary endpoint is the mean time, in hours, to complete a 4.5 mL pre-dialyzer infusion on days 1, 3, and 5, up to 3 hours.

The outcome description gives pump-rate and administration-time context, but the registry record does not report the observed primary endpoint estimate or its variability. It names mean maximum TSAT before and after the dialyzer as secondary outcomes, without reporting their results. The record lists 0 serious adverse events, 0 other adverse events, and 0 deaths in each infusion group. Because the study is sequential and not a randomized, like-for-like comparison, its conditions should not be interpreted as randomized treatment and control groups.