Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution (NCT06358820), a na phase 4 study. The primary outcome is Blood Albumin.

2. Clinical Question

The study's self-controlled structure makes the comparison a before-and-after assessment within participants. That can account for characteristics that remain stable within a participant over the observation period, but it does not by itself distinguish a treatment-associated change from changes over time, changes in other aspects of care, or other influences. The open design also means that masking was not used, according to the registry record. Those features are important when interpreting any reported change: a before-and-after pattern would describe what happened during the study, but would not alone establish that the study treatment caused it.

3. Trial Design

The registry identifies NCT06358820 as a completed Phase 4 study titled “Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution.” Its official title describes a multicenter, open, prospective, self-controlled clinical study in maintenance peritoneal dialysis patients. The sponsor was The People's Hospital of Gaozhou. The recorded start date was 2023-12-03, and the primary completion date was 2025-01-07. Enrollment was 149.

The study used a single-group design. Participants received amino acid peritoneal dialysis solution as part of their daily dialysis regimen for 6 months. The study description states that each participant received 1 bag of amino acid solution per day and 2-4 bags of glucose peritoneal dialysis solution per day. The glucose amount followed the treatment plan selected by the patient during screening. The registry describes participants as serving as their own controls, with measurements before treatment compared with measurements during treatment.

Efficacy and safety evaluations were scheduled before treatment and during the 3rd and 6th months of treatment. The primary outcome was blood albumin change over 6 months. The primary-outcome population was defined by treatment exposure and availability of an efficacy evaluation at at least 1 post-treatment observation time point. The record does not report the number contributing data at each assessment or explain how incomplete follow-up was handled.

There was no randomized allocation and no masking. The registry record does not report a separate concurrent control group. Consequently, the comparison is not between like-for-like randomized groups; its central contrast is within participants over time. This design can describe changes observed during treatment, but by itself it cannot isolate treatment effects from other time-related influences. The record does not report the protocol's sample-size justification, interim analyses, or detailed statistical analysis plan.

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: All included subjects received at least 1 dose of study treatment and had data for efficacy evaluation at at least 1 post-treatment observation time point.

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 Blood Albumin, measured over 6 months.

Blood albumin is a continuous laboratory measure reported in g/L. The registry lists the primary outcome as changes in blood albumin levels, with a 6-month timeframe, and specifies that the outcome is expressed as a mean with standard deviation. Albumin is used in clinical research as one indicator related to nutritional status, which makes it relevant to a study framed around nutritional status in people receiving maintenance peritoneal dialysis. It is not, by itself, a complete description of nutrition or overall health.

The self-controlled design entails comparing participants' measurements before treatment with measurements during treatment. The scheduled assessments were before treatment and during the 3rd and 6th months. The record identifies the primary endpoint timeframe as 6 months; it does not state in the primary outcome description how the change was calculated or which specific baseline-to-follow-up contrast was used for the reported primary analysis.

The registry record does not report the blood albumin means, standard deviations, change estimate, confidence interval, or p-value. It also does not report the number with evaluable blood albumin data at each time point. Therefore, the endpoint definition can be described, but the size, direction, and precision of the observed change cannot be assessed from the record. A change in this measure would be an outcome observation, not by itself proof that the study treatment caused the change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a self-controlled comparison estimate?

In a self-controlled study, measurements from the same participant at different times are compared. The participant serves as their own reference, rather than being assigned to a separate control group. This approach can account for stable participant characteristics that would differ between people in separate groups. It does not control automatically for factors that change over time. For example, changes in health status, concurrent treatment, or ordinary variation in a laboratory measure may occur alongside the intervention. A before-and-after difference therefore describes a temporal change; attribution of that change to treatment requires additional support that this design alone cannot supply.

For this study, assessments were scheduled before treatment and during the 3rd and 6th months of treatment, while the primary endpoint timeframe was 6 months. The registry record does not describe the exact contrast or statistical model used to estimate the primary change. It also does not report whether the analysis used all scheduled visits or how repeated measurements within each participant were handled.

What do mean and standard deviation describe?

A mean describes the central value of a set of continuous measurements. A standard deviation describes how dispersed individual measurements are around that mean. They answer different questions: a mean describes the average measurement, while a standard deviation describes variability among measurements. Neither alone indicates how precisely an estimated change is known. The registry lists mean and standard deviation for blood albumin but does not report their values or the estimated change.

A confidence interval is a statistical range expressing uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval spanning values on both sides of no change may be compatible with several possible underlying effects. These are general interpretations; the registry record does not report a confidence interval for the primary outcome. A p-value, when reported, describes how compatible the observed data are with a specified null model under the analysis assumptions. It does not measure the size or clinical importance of an effect. The registry record does not report a primary-outcome p-value.

Why can repeated measurements matter?

Repeated measurements from one participant are related rather than independent observations. Analyses of longitudinal data need to account for that relationship when estimating uncertainty. The appropriate approach depends on the outcome, data structure, and analysis plan. The registry record does not report the model used for repeated measurements, whether an assumption about within-participant correlation was made, or what diagnostic checks were performed. Those details cannot be inferred from the self-controlled design description alone.

Continuous outcomes may also have distributions that depart from the assumptions of a particular statistical method. In general, model choice and diagnostic assessment matter because they affect how estimates and uncertainty are calculated. The record does not report distributional assessments, transformations, robust methods, or sensitivity analyses for blood albumin. It is therefore not possible to evaluate whether the analysis assumptions were appropriate from the registry description.

What do the sample-size assumptions mean?

The registry's sample-size illustration is described as a planning calculation based on the observed effect, not as the trial's own design justification. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The record further distinguishes calculations for time-to-event outcomes from other outcomes, describing the former as total events and the latter as participants per arm.

Those assumptions describe an illustration, not the actual study design. This trial is a single-group self-controlled study rather than an equal-allocation, two-arm trial. The record does not report the values of any planning illustration in the registry record for this analysis, so no participant requirement can be stated. The illustration should not be interpreted as observed power. In general, power is a design-stage probability under specified assumptions, while a post hoc calculation based on an observed effect does not establish the probability that the trial detected a true effect.

The record does not report the trial's own sample-size justification, target effect, or analysis plan. It would be inappropriate to infer these from enrollment or from the separate illustration assumptions. Enrollment alone does not establish whether a study had adequate precision for the primary endpoint.

How should estimates and safety counts be kept distinct?

An outcome estimate, such as a mean change, describes the measured efficacy endpoint. Safety counts describe the number of participants with recorded events in the relevant category. These quantities answer different questions and use different analysis details. A serious adverse event count does not replace the primary-outcome estimate, and an albumin change does not summarize safety. The registry record gives some safety counts and serious-event terms but does not report the detailed statistical methods for either efficacy or safety analyses.

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("Self Control")
n   <- c(142)
m   <- c(4.02)
sp  <- c(3.64)
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  Self Control  142  4.020  3.640  3.416  4.624

11. Multiplicity, Missing Data and Analysis Populations

The registry record identifies blood albumin change as the primary outcome and lists two outcome measures and two analyses. It does not provide enough detail to determine the full set of statistical hypotheses, how the two analyses relate to the outcome measures, or whether any adjustment for multiple testing was planned. Multiplicity arises when several outcomes, time points, or comparisons are tested: the chance of at least one apparently unusual result can increase as the number of tests grows. Whether adjustment is appropriate depends on the prespecified analysis strategy and the role of each test. The record does not report a multiplicity procedure, so none should be assumed.

The study scheduled assessments before treatment and during the 3rd and 6th months. The record specifies a 6-month primary endpoint timeframe but does not report which time-point comparisons were treated as primary or how other time points were handled statistically. Nor does it state whether analyses at different visits were considered exploratory, secondary, or part of a repeated-measures model.

The primary-outcome population required at least 1 dose and an efficacy evaluation at at least 1 post-treatment observation time point. This definition does not establish that all enrolled participants contributed to the 6-month endpoint. The record does not report the number with measurements at each visit, reasons for missing data, or the method used to handle missing measurements. In general, missing-data methods rely on assumptions about why observations are unavailable; those assumptions cannot be evaluated without details about missingness and the analysis approach.

The registry record also does not report whether sensitivity analyses were conducted to assess the effect of missing data, whether the analysis was restricted to participants completing all scheduled assessments, or whether any other analysis population was used. These omissions limit assessment of the robustness of the primary result. The record does not report a detailed statistical analysis plan, interim analyses, or the timing of any analysis decisions. None of these features can be inferred from the study's completed status or enrollment.

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 0.67% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: peritonitis (11.4%), diabetic foot infection (2.7%), respiratory system infection (2.0%), inguinal hernia (2.0%), gastrointestinal lesions and fatigue (1.3%).

The registry safety group lists 149 participants at risk for serious adverse events and 149 at risk for other adverse events. Serious adverse events affected 31 participants, other adverse events affected 3, and 1 death was reported. The record lists peritonitis at 11.4%, diabetic foot infection at 2.7%, respiratory system infection at 2.0%, inguinal hernia at 2.0%, gastrointestinal lesions and fatigue at 1.3%, and subcutaneous tunnel infection at 0.7% among the top serious-event terms.

These figures should be read as reported safety observations, not as proof that the intervention caused an event. The registry record does not report causal attribution, participant-level timing, duration, or whether the listed serious-event terms overlap for any participant. A count of affected participants is also distinct from a count of event episodes; the record does not clarify all such details. The listed term percentages describe the registry's reported values and should not be reinterpreted as treatment-attributable risks.

The record reports 1 death but does not state its cause or relationship to treatment. It also does not provide detailed information on event severity beyond the serious/non-serious categorization shown, management, or outcomes. These limitations mean the registry figures can describe reported events, but they cannot establish comparative safety or causality.

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

The record describes a completed, open, prospective, multicenter, self-controlled study in maintenance peritoneal dialysis patients. The intervention regimen included 1 bag of amino acid peritoneal dialysis solution per day for 6 months, alongside 2-4 bags of glucose peritoneal dialysis solution per day. The primary endpoint was blood albumin change in g/L at a 6-month timeframe. These details establish what the study set out to assess and how its within-participant comparison was structured.

The record does not report the albumin measurements, estimated change, standard deviation, confidence interval, or p-value. Consequently, it does not show whether the primary outcome increased or decreased, how large any change was, or how precisely it was estimated. It is not possible to judge the magnitude or statistical uncertainty of the primary result from the registry information. The registry record also does not report enough analysis details to evaluate the handling of repeated measurements or missing observations.

Even if a before-and-after change were reported, the single-group self-controlled design would not by itself establish that the intervention caused it. Changes in health, other care, or time may coincide with treatment. The open design and lack of a concurrent randomized comparator also limit causal interpretation. A self-controlled comparison can be informative about observed changes within participants, but it answers a different question from a randomized treatment-versus-control contrast.

The safety record reports serious and other adverse event counts, a death, and several serious-event terms with percentages. These are important descriptive observations, but the record does not report attribution or a comparative safety analysis. The figures therefore should not be taken as proof that treatment caused or prevented any event.

The findings that can be stated from this record are limited to the trial's design, intended primary measure, regimen, schedule, enrollment, and reported safety observations. A conclusion about effectiveness, nutritional benefit, or treatment-related safety would require outcome and analysis information that is not reported in the registry record.

14. Why This Trial Matters Statistically

This trial is statistically notable because its design asks a within-participant question rather than comparing independently assigned treatment groups. Participants served as their own controls, with measurements before treatment and during the 3rd and 6th months. Such a design can be useful for describing change over time and can reduce the influence of participant characteristics that remain stable. At the same time, it remains vulnerable to influences that change alongside treatment, so the design's interpretation differs from that of a randomized controlled comparison.

The primary endpoint, blood albumin, is continuous and reported as a mean with standard deviation. Interpreting such an endpoint requires more than knowing the outcome name: readers need the estimate of change, a measure of uncertainty, and a clear account of the analysis population and method. The registry record does not report those outcome results. This makes the absence of effect size and precision especially important: without them, neither the direction nor the scale of the primary finding can be assessed.

The study also illustrates why safety counts and efficacy estimates should be considered separately. The record gives counts for serious and other adverse events and lists serious-event terms, but does not report causality assessments or comparative safety results. Those counts describe reported events during the study; they do not independently establish a treatment effect.

Finally, planning calculations must match the design they are intended to inform. The record describes a sample-size illustration based on a two-arm equal-allocation assumption, while the study itself is single-group and self-controlled. That illustration is not the trial's own design justification and is not observed power. Careful separation of design, planning assumptions, observed results, and causal claims is essential when reading this trial.

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 most direct limitation of the registry record for interpreting the trial is that it does not report the primary blood albumin results. Means, standard deviations, change estimates, confidence intervals, and p-values are not reported in the registry record. Without these, the size, direction, and precision of any change cannot be evaluated.

The self-controlled design has no randomized concurrent comparator described in the registry record. A pre-treatment measurement offers a within-participant reference but does not control for time trends, changes in other care, or other factors that may vary during follow-up. The study was open, so masking was not used. These features constrain causal inference, even if a change in blood albumin were available.

The primary-outcome population required treatment exposure and at least 1 post-treatment efficacy evaluation. The registry does not report how many participants contributed data at each visit, how many had a 6-month measurement, or why data may have been unavailable. It does not report missing-data methods, the statistical model for repeated measures, or sensitivity analyses. The precision and robustness of any analysis therefore cannot be assessed.

The record also gives limited detail on the analysis plan. Multiplicity procedures, the exact primary contrast, interim analyses, and the trial's sample-size justification are not reported in the registry record. The sample-size illustration is based on a two-arm planning assumption, which differs from the study's single-group structure, and its reported assumptions do not establish the adequacy of the actual study design.

For safety, the record provides event counts and serious-event terms but does not report attribution, event timing, detailed clinical context, or comparative analyses. The reported death has no stated cause or treatment relationship. These limitations mean the safety observations cannot establish causality.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution — NCT06358820.
• Registry record last updated 2025-07-16; status last verified 2025-06.
• Results first posted 2025-07-16.
• 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

NCT06358820 is a completed Phase 4, multicenter, open, prospective, self-controlled study sponsored by The People's Hospital of Gaozhou. The record lists enrollment of 149 and dates of 2023-12-03 for study start and 2025-01-07 for primary completion.

Participants received 1 bag of amino acid peritoneal dialysis solution per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months. Assessments were scheduled before treatment and during the 3rd and 6th months. Blood albumin change in g/L at 6 months was the primary outcome, expressed as a mean with standard deviation.

The registry record reports serious adverse events affecting 31 participants, other adverse events affecting 3, and 1 death, with serious-event terms and percentages also listed. It does not report the primary albumin results, their uncertainty, or the detailed analysis methods. The design is self-controlled rather than a randomized comparison, so observed before-and-after changes would not alone establish causation.