Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients (NCT03408639), a randomized phase 3 study. The primary outcome is Mean Hb Change Level During the Last Four Weeks of Treatment.

2. Clinical Question

3. Trial Design

This is a Phase III, randomized, parallel-group, active-controlled trial of CinnaPoietin® and Eprex® in hemodialysis patients with anemia in end-stage renal disease. The registry lists planned enrollment of 156 and marks the study completed. The listed start date is 2016-06-22 and primary completion date is 2017-07-19. The official title describes a two-armed, patient-and-assessor-blinded trial; the registry’s masking entry is quadruple. The record does not identify all roles covered by that masking classification.

The treatment period is described as 26 weeks. The brief summary says that patients already treated with erythropoietin would continue at a similar previously administered dose, by intravenous or subcutaneous administration, before subsequent response-based adjustment. The arm descriptions also give a starting-dose range for patients new to erythropoietin. These descriptions are registry summaries and do not specify every operational detail of treatment administration or dose adjustment.

The primary endpoint is mean hemoglobin change during week 22 to week 26. Its posted group results include 61 participants for CinnaPoietin® and 38 for Eprex®. These are the endpoint-specific counts, not a participant-flow account. The registry does not report why those counts differ from planned enrollment or provide a complete accounting of participants randomized, treated, or included in each analysis.

The record lists additional outcomes concerning dose changes, hemoglobin measurements, transfusions, treatment success, maintenance success, and safety. It does not report the trial’s original sample-size justification, the non-inferiority margin, detailed allocation procedures, or a full statistical analysis plan. These omissions matter when judging whether the posted comparisons answer the trial’s stated non-inferiority objective.

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

Reasons for not completing this period:

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 Mean Hb Change Level During the Last Four Weeks of Treatment, measured over Week 22 to week 26.

The primary endpoint is the mean hemoglobin change level during the last four weeks of treatment, with the timeframe specified as week 22 to week 26 and the unit given as g/dL. Hemoglobin is a continuous measure, so the endpoint summarizes the average change for each treatment group rather than counting how many participants crossed a threshold. The registry describes the endpoint as a mean and reports a standard deviation for each group.

A group mean offers a compact description of the average observed change, while the standard deviation describes how spread out individual measurements are around that mean. The mean difference then expresses the contrast between the two group averages in the original measurement units. This is useful for comparing average response over the specified treatment period, but it does not describe every participant’s experience or the proportion who met a separate target.

The endpoint is relevant to the trial’s stated efficacy comparison because it focuses on hemoglobin change near the end of treatment. It should not be conflated with the registry’s secondary outcomes, which include threshold-based hemoglobin measures and other clinical or treatment measures. The record does not report a clinically important difference threshold or the non-inferiority margin needed to interpret the primary contrast against a prespecified non-inferiority criterion.

The description does not clarify the reference point used to define “change,” or give details of repeated-measure handling, averaging, or adjustment. Those specifications are not reported in the registry record. Accordingly, interpretation should stay with the endpoint as labeled and the posted group summaries rather than assume a more detailed measurement definition.

7. Results Posted in the Registry

• Eprex®: mean 0.74 versus 0.40 on control; difference 0.34 (95% CI -0.20 to 0.88), standardized effect d = 0.26; z-test p = 0.220.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

The Proportion of Patients With Any Permanent or Transient Dose Change

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Eprex®: 1.5% (1/66) versus 1.4% (1/72) on control; risk difference 0.1 percentage points (95% CI -3.9 to 4.1), risk ratio 1.09 (0.07–17.09); unadjusted two-proportion z-test p = 0.951.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Eprex® and the control. The interval gives the range of effects that remain compatible with the data.

The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Eprex®: 1.4% (1/73) versus 1.4% (1/74) on control; risk difference 0.0 percentage points (95% CI -3.7 to 3.8), risk ratio 1.01 (0.06–15.90); unadjusted two-proportion z-test p = 0.992.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Eprex® and the control. The interval gives the range of effects that remain compatible with the data.

The Percentage of Patients With Hb Measurements More Than 10.0 g/dl

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Eprex®: 85.7% (48/56) versus 80.9% (55/68) on control; risk difference 4.8 percentage points (95% CI -8.3 to 17.9), risk ratio 1.06 (0.91–1.24); unadjusted two-proportion z-test p = 0.475.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Eprex® and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover several different aspects of treatment and clinical status: dose changes, hemoglobin values relative to targets, transfusions, treatment and maintenance success, and other hemoglobin or hematocrit thresholds. Their questions and measurement scales vary, so they should not be combined into one overall treatment effect. Taken as a group, the registry results do not establish a consistent or confirmatory pattern across these distinct outcomes.

These outcomes provide context for the primary endpoint but do not replace it. The primary result concerns mean hemoglobin change during week 22 to week 26, whereas secondary measures include threshold attainment and other treatment events over specified periods. A difference in a threshold-based outcome would not necessarily imply a difference in the group mean, and the reverse is also true. Each measure answers a different question and may have a different number of participants contributing data.

The registry does not list reported analyses for the secondary results represented in the posted comparisons. The comparisons are unadjusted, and the record does not report a multiplicity strategy, outcome hierarchy, or prespecified confirmatory status for these measures. In general, examining many outcomes without an adjustment or prespecified hierarchy makes isolated nominal results less persuasive, because some apparent differences may occur by chance. This is why secondary comparisons should carry less weight than a clearly specified primary analysis.

The secondary findings can be used to describe what was recorded, identify questions for further study, and understand what outcomes the trial monitored. They should not be treated as independent proof of benefit, harm, or equivalence. Their interpretation is further limited by the absence of detailed analysis populations and missing-data methods in the registry record. The posted results are best considered descriptive context alongside the uncertain primary estimate.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• The Proportion of Patients With Any Permanent or Transient Dose Change
• The Proportion of Patients With Any Hb Measurement Outside the Target Range (10-12 g/dl)
• The Proportion of Patients Needed Blood Transfusions
• The Proportion of Patients With Treatment Success
• The Proportion of Patients With Maintenance Success
• The Percentage of Patients With Hb Measurements More Than 10.0 g/dl
• The Percentage of Patients With Hematocrit Measurements More Than 30%
• The Incidence of Hb Levels Above 13 g/dl

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean difference represent?

The primary endpoint is continuous, and the registry reports a mean and standard deviation for each group. A mean is the arithmetic average of the measured changes within that group. The standard deviation describes the degree of variation among individual observations around the group mean; it is not a measure of uncertainty in the mean itself. The comparison is expressed as a mean difference, with Eprex® relative to CinnaPoietin®. A positive estimate means the posted Eprex® group mean is higher on this endpoint; it does not tell whether that difference is important to patients or meets the trial’s stated objective.

For the primary endpoint, the registry posts a mean difference of 0.34 g/dL and an unadjusted p-value of 0.22. The p-value is a measure of how incompatible the observed result is with a specified null model under the assumptions of the test. It is not the probability that the null hypothesis is true, nor does it measure the size or importance of the contrast. Because the p-value is unadjusted, it should not be treated as accounting for multiple outcome comparisons.

What does a non-inferiority objective require?

In general, a non-inferiority trial asks whether the effect of a test treatment is not worse than the comparator by more than a prespecified margin. That margin defines the largest difference considered acceptable for the trial’s question. The analysis also needs a stated direction and decision rule, often interpreted alongside an interval for the treatment contrast. A conventional test for any difference answers a different question: failure to find a statistically detectable difference does not demonstrate that a treatment is non-inferior.

Here, the trial titles state a non-inferiority aim, but the margin and formal analysis decision rule are not reported in the registry record. The displayed mean difference and interval therefore cannot establish whether the criterion was met. The record also does not report a sponsor analysis to supersede the summary calculation. No discrepancy is flagged between a sponsor analysis and the recalculated comparison.

What does the interval communicate?

In general, an interval around an estimate shows the range of values compatible with the data under a statistical procedure and its assumptions. Wider intervals indicate less precision, while narrower intervals indicate greater precision. An interval that includes zero for a difference does not show that the true difference is zero; it shows that zero remains among the values compatible with the reported uncertainty. The interval’s confidence level and calculation method are not reported in the registry record, so they should not be inferred from the endpoints alone.

The primary interval extends from -0.203 to 0.883 g/dL. Its span reflects uncertainty in the estimated mean difference, and it permits interpretations in either direction. The values cannot be assessed against a clinical or non-inferiority boundary because neither boundary is reported. The group standard deviations and endpoint counts contribute to the uncertainty, but the registry does not report details such as covariate adjustment, repeated-measure modeling, or the handling of missing endpoint observations.

Why do analysis populations and missing data matter?

Clinical trials may define several populations for analysis, such as participants randomized, participants who received treatment, or participants meeting protocol requirements. In general, conclusions can differ depending on which population is used, particularly for non-inferiority questions. The registry does not report the primary endpoint population definition, an intention-to-treat or per-protocol analysis, or participant-level reasons for missing outcome data. It lists planned enrollment of 156, while the primary endpoint counts are 61 and 38; no participant-flow explanation is reported.

Missing-data methods also influence estimates when outcomes are unavailable. Common approaches make different assumptions about the unobserved measurements, and those assumptions can affect both the group means and their uncertainty. The registry does not report whether endpoint data were imputed, whether incomplete records were excluded, or how missingness was assessed. The posted group summaries should therefore be interpreted as the results for the endpoint counts shown, without assuming a particular missing-data strategy.

Why does multiplicity matter?

When many outcomes or analyses are examined, the chance of observing a nominally unusual result can increase. General approaches include prespecifying a hierarchy, adjusting a significance threshold, or treating secondary analyses as exploratory. The registry lists multiple secondary outcomes, but the multiplicity strategy and hierarchy are not reported in the registry record. The posted p-values for secondary comparisons are unadjusted. They should not be read as confirmatory evidence across the full outcome set.

These methodological considerations are especially important because the trial’s stated objective is non-inferiority, whereas the available posted primary comparison is a mean difference with an unadjusted p-value. The descriptive estimate is informative about the observed group averages, but a complete interpretation of the planned inferential question would require the margin, analysis population, missing-data approach, and formal analysis plan. Those details are not reported in the registry record.

11. Confidence Intervals and Precision

The primary mean difference is 0.34 g/dL, with a reported interval from -0.203 to 0.883 g/dL. The interval is the most useful posted expression of uncertainty around the difference in group means. It includes zero and values on both sides of zero, so the data do not pin down the direction of the underlying average contrast with high precision. The estimate favors a higher mean change in the Eprex® group, but the interval also allows a small contrast in the other direction.

Precision depends in part on the amount of information in the endpoint groups and the variability of the measurement. The reported standard deviations are 1.26 for CinnaPoietin® and 1.39 for Eprex®, with endpoint counts of 61 and 38. Those counts are specific to the primary endpoint. The registry does not explain why the counts differ, provide participant-flow details, or report how missing observations were handled. These omissions make it difficult to assess the representativeness of the endpoint summaries or the sensitivity of the result to analysis choices.

An interval is not a guarantee that the true effect lies within its limits, and its interpretation depends on the method and assumptions used to construct it. The interval’s confidence level and calculation details are not reported in the registry record. It also cannot answer the non-inferiority question without the prespecified margin. A result can be compatible with no difference yet remain too imprecise to rule out a clinically meaningful disadvantage or advantage. Since no clinical importance threshold is reported, the interval should be described in its original units rather than assigned a clinical verdict.

The p-value of 0.22 is unadjusted and does not replace the interval. Neither statistic establishes equivalence or non-inferiority. The practical reading is that the point estimate is a modest positive contrast for Eprex® relative to CinnaPoietin®, while substantial uncertainty remains around that estimate.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning illustrations express sample size as participants per arm, not total events. They are based on a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. These are planning assumptions for illustrations based on the observed result; the trial’s original sample-size assumptions and justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would be needed for an 80% chance of detecting the selected effect under those assumptions, if that effect were the true effect and the other assumptions held. The 90% power column uses a higher chance of detection, so it generally requires more participants per arm. These values are not observed power.

Rows that plan for 100% of the observed effect use that full observed contrast as the target. Rows that plan for 75% or 50% of the observed effect use smaller targets. A smaller effect is harder to distinguish from random variation, so the planning calculation requires more participants per arm as the target effect shrinks. The figures are illustrations, not a reconstruction of the study’s design, and they do not account for design features or analysis choices that are not reported in the registry record.

Such calculations are sensitive to assumptions about the effect size, variability, significance level, allocation, and statistical method. For binary outcomes, the underlying event rates also influence the illustration. The observed contrast is uncertain, so using it as a planning target does not make it a reliable prediction of the effect in a future study. The registry’s planning assumptions should be kept separate from the trial’s own planned enrollment of 156, which is reported without its original statistical rationale.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.340; pooled standard deviation σ = 1.311.
2. n = 2 × (1.96 + 0.842)² × 1.311² / 0.340² = 233.4, rounded up to 234 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.34                      # observed difference in means
sigma <- 1.31110915506484                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3408639)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 234 (80% power), 313 (90% power)
 75% of observed effect: n per arm = 415 (80% power), 556 (90% power)
 50% of observed effect: n per arm = 934 (80% power), 1,250 (90% power)
power.t.test: 234.4 
Simulated power at n = 234 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The record lists numerous secondary outcomes in addition to the primary endpoint. When multiple outcomes are tested, the probability of at least one apparently notable result can rise, even if no true effect exists for any particular comparison. This general multiplicity issue is one reason to distinguish a prespecified primary question from secondary or exploratory analyses.

The registry does not report a multiplicity adjustment, testing hierarchy, or a plan specifying which secondary outcomes were intended to support confirmatory conclusions. The posted secondary comparison p-values are unadjusted. They should therefore be read as descriptive evidence for their individual comparisons, not as controlling the overall chance of false-positive findings across the outcome set. The record also does not report whether outcomes were selected or prioritized before the data were examined.

Participant flow and analysis populations are not adequately detailed in the posted record. Planned enrollment is 156, while the primary endpoint group counts are 61 and 38. The registry does not explain the difference, identify the numbers randomized to each group, or describe withdrawals and exclusions. It also does not define whether the primary result is based on an intention-to-treat population, a per-protocol population, or another set of participants. These details are particularly important for a non-inferiority objective, where analysis population choices can influence interpretation.

Missing-data handling is not reported in the registry record. There is no description of the amount or reasons for missing outcome measurements, any imputation strategy, or sensitivity analyses. Without those details, readers cannot assess whether the posted endpoint summaries might depend on assumptions about unobserved data.

The record does not provide a full statistical analysis plan, the non-inferiority margin, the formal decision rule, or a sponsor-reported analysis for the primary comparison. It also does not report interim analyses or stopping rules. These items are not reported in the registry record, and no assumptions about them should be made. Consequently, the posted values support a descriptive reading of the available results but do not supply all of the methodological information needed to reproduce or fully evaluate the trial’s intended inferential analysis.

15. 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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: (skin reaction, catheter defect, disability catheter, filter clots, pain in injection site, skin rea (5.1%), palpitation, cardiac function impairment, cardiac infraction, chest pain, tachycardia) (3.8%), (pneumonia, infection of right hand lower than the fistula) (2.6%), (co toxicity, transplantation complication) (2.6%), (tearing of tendon in both knees, back pain, musculoskeletal-bone pain, knee tenderness due to joint (2.6%).

The registry reports serious-event figures for 78 participants at risk in each treatment group. The serious-event affected counts are 14 for CinnaPoietin® and 7 for Eprex®. For other adverse events, the affected counts are 11 and 12, respectively. The record also reports 5 deaths in each group. These are the registry’s posted counts; the record does not provide enough detail to determine event timing, severity grading beyond the serious classification, relatedness, or whether counts represent unique participants or event episodes.

Serious adverse event counts are important for describing observed safety experience, but they do not by themselves show that one treatment is safer. A comparative safety assessment would need the relevant definitions, exposure and follow-up details, participant-level accounting, and uncertainty around the group contrast. The registry record does not report a formal comparative safety analysis or an adjustment for differences in exposure. The serious-event terms are also listed in grouped and partly abbreviated descriptions, limiting interpretation of individual event categories.

These figures should be read separately from the primary hemoglobin result. They describe reported adverse-event experience, not treatment efficacy, and they do not establish causation. The record’s posted safety information is a summary rather than a complete safety analysis.

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

The posted primary result describes a mean hemoglobin change of 0.4 g/dL for CinnaPoietin® and 0.74 g/dL for Eprex® during the specified late-treatment period. The estimated mean difference is 0.34 g/dL for Eprex® relative to CinnaPoietin®, with an interval from -0.203 to 0.883 g/dL. This gives a quantitative summary of the observed group contrast and its reported uncertainty.

That result does not establish that either treatment is clinically superior. The interval includes zero, and the record does not state a threshold for clinical importance. It also does not establish that the products are equivalent. Equivalence requires prespecified margins and an analysis designed to support that conclusion, and such margins are not reported in the registry record.

Nor does the result by itself show non-inferiority, despite the trial’s stated objective. A non-inferiority conclusion requires a prespecified margin and a comparison of the uncertainty around the treatment contrast with that margin. The record does not report the margin or formal decision rule. A nonsignificant unadjusted p-value is not a substitute for that evidence.

The endpoint counts and standard deviations describe the available group summaries, but the record does not explain participant flow, analysis population, or missing-data handling. These limitations make it harder to know how broadly the primary result represents the randomized population. The secondary outcomes and safety counts add descriptive context, but their unadjusted status and missing analysis details mean they should not be treated as definitive comparative conclusions.

The appropriate interpretation is therefore bounded: the registry posts a modest positive mean contrast for Eprex® relative to CinnaPoietin®, but the uncertainty remains compatible with differences in either direction. The posted information does not answer every methodological question required for a formal non-inferiority assessment, and it cannot determine clinical importance without a stated threshold.

17. Why This Trial Matters Statistically

This trial illustrates why the label of a trial objective and the statistical evidence needed to support that objective must be considered together. A study described as non-inferiority cannot be judged from a conventional difference estimate and p-value alone. The margin and decision rule determine what degree of disadvantage would still meet the trial’s objective. Without those details, a nonsignificant difference is not evidence that two treatments are sufficiently similar.

The primary result also shows the value of reading an estimate alongside its uncertainty. The point estimate is 0.34 g/dL, but the reported interval ranges from -0.203 to 0.883 g/dL. The point estimate alone could invite an overly definite interpretation; the interval makes clear that a broad set of contrasts remains compatible with the posted data. Statistical precision and clinical importance are separate questions, and no clinical threshold is reported.

The registry also provides a practical reminder that a planned enrollment figure and endpoint-specific counts answer different questions. Planned enrollment is 156, while the primary result uses group counts of 61 and 38. Without participant flow and analysis-population definitions, readers cannot reconstruct how those endpoint counts arose or evaluate the consequences for the analysis.

Finally, multiple secondary outcomes and safety summaries broaden the clinical questions but do not automatically strengthen the primary conclusion. Their measures differ, and the registry does not report a multiplicity plan or formal analyses for the secondary comparisons. Treating each nominal comparison as definitive would overstate what the record establishes. The trial is statistically instructive because it combines a stated non-inferiority goal with incomplete reporting of key inferential details, making careful separation of observed estimates, uncertainty, and formal conclusions essential.

18. 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.

Several limitations specific to this record constrain interpretation. The primary endpoint counts are 61 for CinnaPoietin® and 38 for Eprex®, whereas planned enrollment is 156. The registry does not report a participant-flow account explaining the difference, including the numbers randomized, treated, withdrawn, or excluded from this endpoint. It is therefore not possible to determine from the record whether the groups contributing endpoint data represent the randomized groups in the intended way.

The trial is described as non-inferiority, but the margin, formal decision rule, and analysis population are not reported in the registry record. Those are central elements for evaluating the stated objective. The record also does not give a full statistical analysis plan, the interval calculation method or confidence level, adjustment details, or missing-data procedures. The posted mean comparison can be described, but it cannot substitute for the planned inferential analysis if that analysis is unavailable.

The endpoint description does not specify the reference point for “change” or explain how repeated hemoglobin measurements during week 22 to week 26 were summarized. The registry lists secondary outcomes, but it does not report a multiplicity strategy or a hierarchy of tests. Secondary comparisons are unadjusted, so isolated findings would require caution.

The safety summary reports counts without a full comparative analysis, exposure accounting, event timing, or detailed attribution. The serious-event term listings are partly grouped or abbreviated. The registry record also does not report interim analyses or stopping rules. These reporting gaps do not prove that the trial lacked such procedures; they mean those details are not reported in the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Comparing Efficacy and Safety of CinnaGen Beta Erythropoietin (CinnaPoietin®) Versus Eprex® on the Treatment of Anemia in ESRD Hemodialysis Patients — NCT03408639.
• Registry record last updated 2019-12-18; status last verified 2019-12.
• Results first posted 2019-11-06.
• 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.

22. Record Summary

NCT03408639 is a completed Phase III randomized parallel-group trial comparing CinnaPoietin® with Eprex® for anemia in end-stage renal disease patients receiving hemodialysis. Planned enrollment was 156, and the treatment period was described as 26 weeks. The primary endpoint was mean hemoglobin change during week 22 to week 26.

The posted primary mean difference was 0.34 g/dL for Eprex® relative to CinnaPoietin®, with a reported interval from -0.203 to 0.883 g/dL and an unadjusted p-value of 0.22. The interval includes zero, and the registry does not report the non-inferiority margin needed to assess the trial’s stated objective.

Secondary outcomes address several distinct measures, and the record posts safety counts. The registry does not report a full analysis plan, participant flow, analysis population, missing-data approach, or multiplicity strategy. Results therefore support descriptive interpretation, while important details for a formal non-inferiority and comparative safety assessment are not reported in the registry record.