Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (NCT01341782), a randomized phase 3 study. The primary outcome is Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia.

2. Clinical Question

3. Trial Design

The registry record describes a Phase 3, randomized, double-blind, parallel-group trial comparing paricalcitol injection with maxacalcitol injection. The listed enrollment is 255. The study status is completed; the recorded study start is 2011-05 and primary completion is 2012-04. The sponsor is AbbVie (prior sponsor, Abbott).

Both groups received an active injection and the other treatment’s placebo, supporting masking of the treatment assignment. Paricalcitol began at 2 µg, with a possible adjustment after 2 weeks based on protocol-specified criteria and a maximum dose of 7 µg. Maxacalcitol began at 5 µg or 10 µg depending on whether screening iPTH was < 500 pg/mL or ≥ 500 pg/mL. The listed treatment period was 12 weeks, with dosing at hemodialysis sessions 3 times per week. Further details of maxacalcitol dose adjustment are not reported in the registry record.

The primary outcome was assessed in the per-protocol set rather than being described as an analysis of every randomized participant. That set included randomized participants who completed at least 8 weeks of treatment and met the specified subject-classification conditions before the study blind was broken. The primary outcome combined a biochemical target with a safety condition: target iPTH and no hypercalcemia. The registry record does not report the trial’s original sample-size justification or the assumptions used to plan enrollment.

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:

Analysis population for the primary outcome, as defined in the registry: The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken.

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 Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia, measured over iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13)..

The primary endpoint is the percentage of participants who had target intact parathyroid hormone (iPTH) and no hypercalcemia. Target iPTH was defined as 60-180 pg/mL, based on the average of measurements during the last three weeks of treatment. Calcium was measured throughout the treatment phase, Weeks 1-13. Hypercalcemia meant at least 1 corrected calcium value > 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory.

This combined endpoint reflects both the intended biochemical target and a prespecified calcium-safety condition. A participant counted toward the outcome only if both parts were met. That makes the result different from a measure of iPTH reduction alone or a measure of hypercalcemia alone; it summarizes the joint outcome as a percentage.

In general, a binary percentage endpoint is easy to interpret as the proportion meeting a defined condition. Its meaning depends on the endpoint definition, measurement schedule, and analysis population. The registry record specifies the target and hypercalcemia criteria, but the primary result applies to the per-protocol set, which excludes participants who did not satisfy the stated completion and classification conditions.

7. Results Posted in the Registry

• Maxacalcitol: 30.5% (36/118) versus 27.7% (33/119) on control; risk difference 2.8 percentage points (95% CI -8.8 to 14.3), risk ratio 1.10 (0.74–1.64); unadjusted two-proportion z-test p = 0.638.

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.

Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia

• 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:
  • Maxacalcitol: 39.1% (50/128) versus 34.6% (44/127) on control; risk difference 4.4 percentage points (95% CI -7.4 to 16.2), risk ratio 1.13 (0.82–1.56); unadjusted two-proportion z-test p = 0.465.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Maxacalcitol and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)

• 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:
  • Maxacalcitol: 32.8% (42/128) versus 31.5% (40/127) on control; risk difference 1.3 percentage points (95% CI -10.1 to 12.8), risk ratio 1.04 (0.73–1.49); unadjusted two-proportion z-test p = 0.822.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Maxacalcitol and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline

• 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:
  • Maxacalcitol: 50.8% (65/128) versus 44.9% (57/127) on control; risk difference 5.9 percentage points (95% CI -6.3 to 18.1), risk ratio 1.13 (0.87–1.46); unadjusted two-proportion z-test p = 0.346.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Maxacalcitol and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes cover several related but distinct summaries of iPTH response: a reduction of at least 50% from baseline, target iPTH, and visit-based measures of control. Some definitions also combine reduction or target attainment with absence of hypercalcemia. This broader set helps distinguish a combined biochemical-and-safety outcome from iPTH response alone, but the measures are not interchangeable.

Across the secondary outcomes with posted numerical results, the percentages in the two groups are fairly close, and the reported risk-difference intervals include zero. This overall pattern aligns with the primary result’s lack of a clear separation in the posted summaries. It does not establish that the groups are equivalent, nor does it show that every component of the combined primary endpoint behaved in the same way. Outcomes with no numerical results in the registry record cannot contribute an evidential comparison.

The secondary results should carry less weight than the primary result because they are additional outcomes, and the registry record does not report a multiplicity-adjustment strategy or a complete statistical analysis plan. In general, when many outcomes are examined, the chance of finding an apparently noteworthy result by chance can increase unless the analysis accounts for the multiplicity or the outcomes are interpreted with appropriate restraint. The record also does not report whether any secondary findings were prespecified in a detailed analysis plan.

Accordingly, the secondary outcomes are best used to describe the breadth and consistency of the reported pattern, not as independent confirmation of a treatment difference. Their definitions, timeframes, and analysis populations should be kept in view when comparing them with the primary endpoint. Visit-based outcomes may capture repeated control over treatment, whereas participant percentages summarize whether a participant met a condition. Numeric visit-based results are not reported in the registry record.

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

• Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia
• Percentage of Participants With Target Intact Parathyroid Hormone (iPTH)
• Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
• Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline
• Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL

9. Statistical Interpretation

10. Statistical Methods Explained

What is being compared?

The primary outcome is binary at the participant level: each participant either met the combined endpoint or did not. The posted group percentages summarize the proportion meeting it. The comparison is expressed as a risk difference, with maxacalcitol relative to paricalcitol. A risk difference describes the absolute contrast between the proportions, rather than comparing them as a ratio.

In general, the sign of a risk difference depends on the order of the groups. Here, the comparison is identified as maxacalcitol relative to paricalcitol, and the reported estimate is 0.028. Its confidence interval runs from -0.088 to 0.143. Because the interval includes zero, the data do not distinguish a difference from no difference at the conventional level suggested by the unadjusted p-value. The p-value is 0.638. It is a measure of how unusual results at least as incompatible with a no-difference model would be under the assumptions of that test; it is not the probability that either treatment is better.

Why is the analysis population important?

The primary outcome uses the per-protocol set. The registry defines this as randomized participants who completed at least 8 weeks of treatment and met subject-classification conditions, including no specified inclusion or exclusion criteria violation before the blind was broken. This means the primary result is not described as an intention-to-treat analysis of all randomized participants. Per-protocol and intention-to-treat analyses can address different questions: in general, a per-protocol analysis focuses on participants meeting protocol conditions, while an intention-to-treat analysis retains participants in their randomized groups. The registry record does not report an intention-to-treat result for the primary endpoint.

What does the confidence interval add?

In general, a confidence interval gives a range of values reasonably compatible with the observed data and the method used to calculate it. It is not a guarantee that the true effect lies within the interval, and it does not describe the spread of individual participant outcomes. For this risk difference, the interval extends across zero and covers differences in both directions. That uncertainty is essential to interpretation: the point estimate alone would give an incomplete account of what the data support.

How should the p-value be used?

The p-value is reported as unadjusted. In general, an unadjusted p-value evaluates a specified comparison without accounting for the number of other outcomes or comparisons considered. It should not be treated as a stand-alone measure of effect size, precision, or clinical importance. The registry record does not report a multiplicity adjustment or a complete statistical analysis plan. The p-value is therefore best read alongside the risk difference, confidence interval, outcome definition, and analysis population.

What can be concluded from the posted summaries?

The posted summaries support describing the observed percentages and the estimated contrast, with its uncertainty. They do not disclose enough detail to reconstruct all analytic choices. In particular, missing-data procedures, the original analysis plan, and a formal strategy for handling multiple outcomes are not reported in the registry record. General statistical principles can clarify what the displayed quantities mean, but they cannot fill those reporting gaps or establish unreported properties of the trial’s analysis.

11. Confidence Intervals and Precision

The primary percentages have reported 95% confidence intervals: 27.7% for paricalcitol, with an interval from 19.92 to 36.68, and 30.5% for maxacalcitol, with an interval from 22.37 to 39.66. These intervals describe uncertainty around each group’s percentage under the method used. They are not ranges containing a specified fraction of individual participants, and they do not measure variation in treatment response from person to person.

For the between-group risk difference, the estimate is 0.028 and the 95% confidence interval extends from -0.088 to 0.143. The interval includes zero and also allows differences in either direction. This is why the numerical point estimate should not be treated as a precise determination of which group has the higher underlying percentage. The unadjusted p-value, 0.638, is consistent with the interval’s inclusion of zero, but neither statistic establishes equivalence.

In general, precision depends on the amount and distribution of information in the data, the event frequency, and the analysis method. A confidence interval’s width is useful for judging how much uncertainty remains, while its position relative to zero helps describe the direction of effects compatible with the data. The registry record supplies intervals but does not give a separate formal assessment of clinical importance. It also does not report adjusted intervals or a multiplicity procedure. These limits matter because the primary endpoint is one among several outcomes considered in the trial record.

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 sample-size figures are planning illustrations based on the observed effect, not a reconstruction of the trial’s original design assumptions. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each scenario sets the effect to detect at the stated fraction of the observed effect. The figures for these binary outcomes are participants per arm, not total events.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect under the stated assumptions, if that effect is the true effect. The 90% column makes the corresponding illustration for 90% power. Higher power generally requires more participants under otherwise unchanged assumptions. The rows for 100%, 75%, and 50% of the observed effect illustrate how the planning number changes as the effect to detect becomes smaller. Smaller effects need more participants to detect reliably.

These figures are not observed power. They are planning scenarios derived from the observed effect, and they should not be read as evidence that the completed trial had a particular chance of detecting its result. The registry record does not report the assumptions used for the trial’s own sample-size calculation, so the illustration cannot establish whether the original design was adequately powered for the primary endpoint or secondary outcomes.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.277; treatment proportion p₁ = 0.305; average p̄ = 0.291.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6425 = 1.2593.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6422 = 0.5405.
4. n = (1.2593 + 0.5405)² / (0.0278)² = 4,199.1, rounded up to 4,200 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
p0 <- 0.277310924369748                          # control proportion
p1 <- 0.305084745762712                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1341782)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 4,200 (80% power), 5,621 (90% power)
 75% of observed effect: n per arm = 7,414 (80% power), 9,924 (90% power)
 50% of observed effect: n per arm = 16,561 (80% power), 22,169 (90% power)
power.prop.test: 4199.1 
Simulated power at n = 4,200 per arm: 0.799 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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 registry record lists several secondary outcomes in addition to the primary endpoint. It does not report a multiplicity adjustment, a hierarchical testing procedure, or another stated method for controlling the interpretation of multiple comparisons. This absence limits how strongly isolated secondary p-values, if available, could be interpreted. In general, examining many outcomes creates more opportunities for chance findings, so secondary results are usually treated as supportive or exploratory unless a prespecified strategy explains how they are to be evaluated.

The primary comparison is reported with an unadjusted p-value. The record does not provide a full statistical analysis plan explaining whether the primary comparison was the sole confirmatory test, whether other tests were planned, or how any testing sequence was defined. The absence of reported details should not be read as evidence that no plan existed; it means that the plan is not reported in the registry record.

Missing-data methods are also not reported in the registry record. The available description identifies the per-protocol population and its completion and classification conditions, but it does not say how missing endpoint measurements, withdrawals, or incomplete follow-up were handled in the primary analysis. The posted group counts for the primary endpoint are 119.0 for paricalcitol and 118.0 for maxacalcitol, while the adverse-event groups use different listed denominators. Those differences reinforce the need to interpret each result within its stated analysis population rather than treating denominators as interchangeable.

The record does not report an intention-to-treat analysis for the primary outcome, an imputation procedure, sensitivity analyses for missing data, or an interim-analysis plan. It also does not report the original sample-size justification. These are limits on assessment of the analysis process, not proof that a particular method was or was not used. The interpretation therefore rests on the posted endpoint definitions, populations, estimates, and intervals, with unreported analytic choices left unresolved.

15. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: shunt stenosis (1.6%), nausea (1.6%), shunt occlusion (1.6%), sinus bradycardia (0.8%), gastric ulcer haemorrhage (0.8%).

The adverse-event summary lists serious adverse events for groups of 127 participants receiving paricalcitol and 128 receiving maxacalcitol. Serious adverse events affected 10 participants in the paricalcitol group and 15 in the maxacalcitol group. Other adverse events affected 118 and 123 participants, respectively. These are reported counts; the summary does not provide a comparative confidence interval or p-value for these safety counts.

The listed serious-event terms include shunt stenosis, nausea, and shunt occlusion, each reported as 1.6%, and sinus bradycardia, gastric ulcer haemorrhage, and gastrooesophageal reflux disease, each reported as 0.8%. The terms and percentages describe the posted serious-event summary; they do not by themselves establish a causal relation to treatment or a comparative difference between groups.

Deaths are not reported in the registry record. The adverse-event information should be read separately from the primary efficacy endpoint, which used a per-protocol population and a defined calcium condition. Safety denominators and populations are not identical to the primary analysis population. The registry record does not provide enough detail to assess event timing, exposure-adjusted rates, or adjusted comparisons.

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

The result describes the proportion of participants in the per-protocol set who met a specific combined condition during a 12-week treatment period: target iPTH based on the average over the last three treatment weeks, with no hypercalcemia during the treatment phase. The observed percentages were 27.7% for paricalcitol and 30.5% for maxacalcitol. The estimated risk difference was 0.028, and its 95% confidence interval ranged from -0.088 to 0.143.

Those data do not establish a clear difference between the treatments on this endpoint. The interval includes zero and allows for effects in either direction. At the same time, the result does not show that the treatments are equivalent: no equivalence margin is reported, and the interval does not rule out differences simply because the unadjusted p-value is 0.638. Absence of a statistically persuasive difference is not proof of no difference.

The result also does not provide a complete account of iPTH response, calcium outcomes considered separately, longer-term outcomes, or outcomes outside the population and period described. The endpoint’s joint definition means that a participant who did not meet either condition did not meet the combined outcome, but the posted primary percentages alone do not reveal which component determined that result for each participant.

The study record describes a comparison in Japanese adults with chronic kidney disease receiving hemodialysis and having secondary hyperparathyroidism. Generalization beyond that clinical setting, treatment schedule, analysis population, or follow-up period is not established by these results. The findings are statistical descriptions of the posted trial data, not medical advice and not a recommendation to choose or avoid either treatment.

17. Why This Trial Matters Statistically

This trial illustrates why a combined endpoint needs to be read according to each part of its definition. The primary outcome required target iPTH and no hypercalcemia, so it represents a joint success condition rather than a single laboratory measure. A percentage meeting that definition can be useful for summarizing how often the prespecified combination occurred, but it does not isolate the contribution of each component.

The result also demonstrates the distinction between an observed point estimate and the uncertainty around it. The percentages differ numerically, yet the estimated risk difference has a confidence interval that includes zero and extends in both directions. Reporting the estimate alongside its interval is more informative than relying on a single p-value or on the direction of the point estimate alone.

Analysis population is another important statistical feature. The primary outcome is reported for a per-protocol set, while adverse-event summaries use their own listed group denominators. Those populations answer different questions and should not be collapsed into a single account of the trial. The record’s limited reporting of missing-data procedures and multiplicity also shows why registry results are best interpreted alongside transparent descriptions of the analysis plan and execution.

Finally, the planning illustrations make clear that sample-size calculations depend on the effect one aims to detect and the assumptions used. They are not a retrospective measure of whether the trial’s result was informative, and they do not substitute for the original design justification. Together, these points encourage interpretation that is precise about endpoint, population, contrast, and uncertainty.

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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The primary result is reported for the per-protocol set, defined by treatment completion and subject-classification criteria. The registry record does not report a primary intention-to-treat analysis or explain how participants excluded from the per-protocol set were handled in other analyses. This limits assessment of how sensitive the result is to the chosen analysis population.

The registry record does not report missing-data procedures, sensitivity analyses, or a detailed statistical analysis plan. It also does not report the trial’s original sample-size justification, multiplicity strategy, or interim-analysis plan. These absences constrain assessment of whether analysis decisions were prespecified and how uncertainty from incomplete information was addressed; they do not establish that the procedures were absent from the trial itself.

The primary endpoint combines target iPTH and no hypercalcemia, so its percentage does not show the separate contribution of each condition. The primary timeframe is limited to iPTH measurements during the last three treatment weeks and calcium measurements throughout the treatment phase. Longer-term outcomes are not reported in the registry record.

Although the trial is described as randomized and double-blind, the posted summaries do not provide detailed information on allocation concealment, adherence, or deviations by group. The comparison estimates are unadjusted, and the registry record does not report a multiplicity adjustment. Safety summaries provide counts and selected serious-event terms, but comparative uncertainty measures and deaths are not reported in the registry record. These reporting limits call for a measured interpretation of both the efficacy and safety summaries.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism — NCT01341782.
• Registry record last updated 2013-06-06; status last verified 2013-04.
• Results first posted 2013-06-06.
• 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

The registry record describes a completed, randomized, double-blind, parallel Phase 3 trial comparing paricalcitol injection with maxacalcitol injection in Japanese adults receiving hemodialysis for chronic kidney disease with secondary hyperparathyroidism. Listed enrollment was 255, and the treatment period was 12 weeks.

The primary endpoint was the percentage meeting target iPTH and no hypercalcemia in the per-protocol set. The posted percentages were 27.7% for paricalcitol and 30.5% for maxacalcitol; the risk-difference interval included zero. The registry record lists related secondary outcomes and safety summaries, but does not report several analysis details, including missing-data methods and multiplicity handling.