This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD) (NCT03812679), a na na study. The primary outcome is Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03812679 |
| Phase | NA |
| Condition | End Stage Renal Disease (ESRD) |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vantive Health LLC |
| Results posted | Yes |
2. Clinical Question
Population
The study concerns patients with end stage renal disease (ESRD). The registry describes the dialysis solution as indicated for adult patients with acute or chronic renal failure when non-dialytic medical therapy is judged inadequate, but specific eligibility criteria and details of the enrolled participants are not reported in the registry record.
Intervention
The intervention is the AMIA APD Solution Generation System, a device system described as combining an updated AMIA APD Cycler with the Sharesource Platform, an in-home water system technology, and AMIA APD Concentrates. The concentrates are diluted by the system to generate dialysis solution. The registry describes collection of generated solution from the heater bag for chemical testing.
Comparator
There is no separate control group in the registry record. The study is listed as a single-group evaluation, with allocation recorded as NA and masking as none. For the chemical composition assessment, samples are compared with specifications for Baxter's approved low calcium Dianeal PD solution. That specification is a benchmark for the solution tests, not a concurrent participant control arm.
Primary question
The primary question is whether tests of the generated dialysis solution meet the specified chemical-composition limits at the stated visits. The registry describes nine test methods and classifies an individual test as not meeting specifications if any measured value is outside its limits. The primary outcome results are not reported in the registry record, so the record does not establish how often specifications were met.
3. Trial Design
NCT03812679 is a single-group device evaluation of the AMIA APD Solution Generation System in patients with ESRD. The registry lists enrollment of 22 and identifies Vantive Health LLC as the sponsor. The study began on 2018-12-20, had a primary completion date of 2020-02-19, and is listed as terminated. The reason for termination is not reported in the registry record.
The study has no randomized allocation or separate comparator arm; allocation is recorded as NA, and masking is listed as none. The registry lists phase as NA. These features matter when interpreting the evidence: the design is not a randomized comparison of the system against another treatment or device, and it cannot support a direct between-group estimate.
The intervention description identifies a system combining an updated AMIA APD Cycler with the Sharesource Platform, an in-home water system technology, and AMIA APD Concentrates. The registry describes simulated treatment before the patient receives study treatment, during week 1, and after 4, 8 and 12 weeks of the study-treatment period. Generated solution is collected from the heater bag for chemical evaluation. The record does not establish which of these planned procedures were completed by each participant.
The primary outcome concerns chemical composition of the generated dialysis solution at Week 1, 4, 8 and 12. A secondary outcome is change from baseline in total Kt/Vurea at Week 5, 6, 7, or 8. The registry lists four outcome measures, but does not report outcome values or analyses. Further details about eligibility, the intended sample-size justification, protocol deviations and reasons for stopping are not reported in the registry record.
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
| Stage | AMIA APD Solution Generation System |
|---|---|
| STARTED | 22 |
| COMPLETED | 14 |
| NOT COMPLETED | 8 |
Reasons for not completing this period:
| Reason | AMIA APD Solution Generation System |
|---|---|
| Adverse Event | 2 |
| Missed >4 consecutive therapy days | 1 |
| Renal transplant | 1 |
| Withdrawal by Subject | 1 |
| Termination of study | 2 |
| Water device replacement | 1 |
Analysis population for the primary outcome, as defined in the registry: Safety Set used for analysis population. Also, Overall Number of Tests Analyzed (N) was captured, along with number of evaluable tests (n) for each individual timepoint.
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.
Population: The Safety Set was based on the Intent-to-Treat principle and included all patients who received at least one treatment with the AMIA APD Solution Generation System and who had at least one measurement for the primary endpoint (either primary efficacy or primary safety).
| Characteristic | Unit | AMIA APD Solution Generation System |
|---|---|---|
| Participants analysed | 22 | |
| Age, Continuous | years | 61.9 (SD 13.67) |
| Sex: Female, Male: Female | Participants | 14 |
| Sex: Female, Male: Male | Participants | 8 |
| Race/Ethnicity, Customized: Asian | Participants | 5 |
| Race/Ethnicity, Customized: Black or African American | Participants | 7 |
| Race/Ethnicity, Customized: White | Participants | 9 |
| Race/Ethnicity, Customized: Other | Participants | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Tests Meeting Specifications for the Chemical Composition of Final Dialysis Solution by Visit, measured over Week 1, 4, 8 and 12.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Percentage of Tests |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns the percentage of tests meeting specifications for the chemical composition of the final dialysis solution at Week 1, 4, 8 and 12. The registry says generated solution from simulated treatment is sampled from the heater bag and compared with specifications for Baxter's approved low calcium Dianeal PD solution. Nine methods are listed: pH at 25 C, Color, 5- (hydroxymethyl)furfural (5HMF), Dextrose hydrous Assay (1.5%, 2.5% or 4.25%), Sodium Lactate Assay, Sodium Assay, Chloride Assay, Magnesium Chloride Hexahydrate (MgCl2.6H2O) Assay, and Calcium Chloride Dihydrate (CaCl2.2H2O) Assay. Measurements are described as being collected with instruments such as meters and chromatography.
The endpoint is used to assess whether the system-generated solution falls within specified chemical limits. Under the registry's description, if any value falls outside the limits, the particular test is considered not to meet specifications. The record says overall tests analyzed and evaluable tests were captured at each timepoint. It also describes reporting the percentage of participants meeting and not meeting specifications, while the outcome title and unit refer to tests. This difference in wording makes it important to distinguish participant-level summaries from test-level denominators. The endpoint results and the exact denominators at each visit are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes an evaluation of whether generated dialysis solution met chemical specifications, not a randomized comparison of clinical outcomes between treatment groups. It lists a single group, enrollment of 22, and no masking. The primary outcome is described for Week 1, 4, 8 and 12, but the registry record does not report the percentage meeting specifications, the number of tests analyzed, or the number evaluable at any visit. As a result, the posted record does not quantify the primary endpoint or its precision.
The endpoint description gives a rule for classifying a test: if any value is outside the limits, that test is considered not to meet specifications. This makes the unit of interpretation consequential. A count or percentage of participants, individual tests, or test methods would answer different questions. Although the outcome title refers to tests and the unit is percentage of tests, the description says results will be reported as percentages of participants meeting or not meeting specifications. The registry also says overall tests analyzed and evaluable tests were captured. The exact reporting denominator and any handling of repeated measurements are not reported in the registry record.
No statistical analyses are listed: the registry records zero analyses. It does not report confidence intervals, hypothesis tests, adjusted estimates, or a statistical analysis plan. Therefore, there is no posted estimate from which to assess uncertainty, compare visits, or determine whether performance changed over time. No interpretation of the system's measured chemical performance can be drawn from the endpoint data in this record.
The secondary outcome is change from baseline in total Kt/Vurea at Week 5, 6, 7, or 8. Its values and analysis are not reported in the registry record. The registry does list serious and other adverse-event counts, which describe safety events rather than chemical composition or dialysis adequacy. Those counts do not fill the gap in primary endpoint results.
The record is marked terminated, but does not state why. Termination alone does not establish that the device performed well or poorly, that a safety concern arose, or that the study ended for a particular operational reason. The record also does not give an account of whether all planned visits or assessments were completed. Conclusions should therefore remain limited to the study's stated purpose, its single-group structure, and the posted event counts; the primary and secondary efficacy or performance results remain unknown in the registry record.
9. Statistical Methods Explained
What is the outcome measuring? The primary outcome is a chemical-specification assessment of dialysis solution generated by the system. The registry describes sampling from the heater bag after simulated treatment and comparison with specifications for Baxter's approved low calcium Dianeal PD solution. The listed methods cover solution characteristics and assays for constituents. The registry defines a failure at the individual-test level: a value outside its limits makes that test not meet specifications. This is a rule for classifying measurements, not a statistical test of a treatment effect.
The record's wording shifts between tests and participants. The title and unit refer to tests, while the description says percentages of participants meeting or not meeting specifications will be reported. It also says overall tests analyzed and evaluable tests are captured at each timepoint. These denominators are not interchangeable. A participant can contribute more than one measurement, and a test may be unevaluable; the registry does not report how these situations were summarized. The outcome values and visit-specific denominators are not reported in the registry record.
What would a percentage describe?
In general, a percentage is interpretable only alongside its denominator and the rule used to count an event. For this endpoint, readers would need to know whether the calculation is based on participants or individual tests, how many observations were evaluable, and how a participant with more than one result is represented. Those details help determine what population or set of measurements the percentage describes. The registry says these counts were captured, but does not post them or the endpoint percentages.
Why do repeated measurements matter?
In general, repeated observations from the same participant are related rather than independent. A method that treats every measurement as unrelated could understate uncertainty if that dependence is ignored. Repeated measurements can also be summarized by visit, by participant across visits, or through a model that accounts for within-participant correlation. The registry specifies assessment visits for the primary outcome, but the method used to analyze repeated measurements is not reported in the registry record. No visit-to-visit estimates or uncertainty intervals are posted.
What can be inferred from an absent analysis?
The registry records zero analyses. It does not identify a statistical model, estimation method, confidence-interval procedure, or hypothesis test for the primary outcome. In general, a confidence interval describes a range of values compatible with an estimate under the method's assumptions; it communicates precision as well as the point estimate. Without an estimate and interval, the precision of the chemical-composition results cannot be assessed. A missing p-value is not evidence for either a positive or a negative result.
The record's sample-size assumptions describe a planning illustration, not the study's own design justification. They specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set as a stated fraction of an observed effect. The record says time-to-event illustrations use a total number of events and other illustrations use participants per arm. This trial, however, is a single-group study, and no observed effect or calculated sample-size values are reported in the registry record. The planning assumptions should not be mistaken for the actual design, a justification for enrollment of 22, or observed power. In general, power calculations are planning tools; they do not measure the probability that a reported result is true.
Why can over-dispersion matter in general?
For count or proportion data, a simple statistical model may assume more regular variation than is present in the observations. Over-dispersion means that the data vary more than such a model expects. If it is ignored, estimated uncertainty can be too small and statistical conclusions can be unreliable. This is a general issue in analysis, not a reported feature of this study: the registry does not report an over-dispersion assessment or the model used for the primary endpoint.
The record does not report whether analyses were adjusted for baseline values, participant characteristics, or multiple visits and test methods. Nor does it report any interim analyses. The absence of these details means readers cannot reconstruct the inferential approach or assess its assumptions from the registry record. Statistical methods should not be attributed to the study unless they are documented there.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome covers nine test methods and multiple visits: Week 1, 4, 8 and 12. The record does not report whether each method and visit was treated as a separate endpoint, combined into an overall summary, or assessed under a prespecified hierarchy. It also does not report a multiplicity adjustment or a statistical analysis plan. In general, testing many outcomes or timepoints can increase the chance of at least one apparently unusual result, so a planned strategy for interpreting multiple comparisons can matter. No inferential results are posted, so there are no reported p-values to adjust or interpret.
The primary outcome identifies the Safety Set as the analysis population. The record does not define that set further. It says the overall number of tests analyzed and the number of evaluable tests were captured at each timepoint, but their values are not reported in the registry record. The secondary outcome is change from baseline in total Kt/Vurea at Week 5, 6, 7, or 8; its analysis population and missing-data handling are not reported in the registry record.
The record does not explain how missing measurements, unevaluable samples, missed visits, or withdrawals were handled. It does not state whether any imputation was performed, whether analyses used only observed data, or how participants with incomplete follow-up were included. These gaps matter because the amount and pattern of missing data can affect which observations contribute to an estimate. Without the denominators, missingness information, and analysis methods, the completeness and potential impact of missing endpoint data cannot be assessed. No interim analyses are reported.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| AMIA APD Solution Generation System | 3 | 22 | 13.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AMIA APD Solution Generation System | 0 of 22 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| AMIA APD Solution Generation System | 2 of 22 |
Most frequent serious adverse event terms
| Event term | Organ system | AMIA APD Solution Generation System |
|---|---|---|
| Atrial fibrillation | Cardiac disorders | 1 of 22 |
| Peritonitis | Infections and infestations | 1 of 22 |
| Peritonitis bacterial | Infections and infestations | 1 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AMIA APD Solution Generation System |
|---|---|---|
| Hypotension | Vascular disorders | 2 of 22 |
Serious events with the highest arm-level rate: atrial fibrillation (4.5%), peritonitis (4.5%), peritonitis bacterial (4.5%).
The registry lists 22 participants at risk for serious adverse events and 3 affected, and 22 at risk for other adverse events and 2 affected. It reports 0 deaths. These are counts, not comparative risk estimates: the study has one group and no concurrent control arm. The record does not report event timing, exposure duration, severity grades beyond the serious-event grouping, or whether events led to treatment changes or withdrawal.
The listed serious-event terms are Atrial fibrillation, Peritonitis, and Peritonitis bacterial, each shown as 4.5%. These are registry-reported term percentages. The record does not explain whether the terms occurred in the same or different participants, so they should not be added or treated as mutually exclusive. Nor does the record provide enough detail to attribute an event to the device or determine causality. The listed terms describe reported serious events; they do not by themselves establish a causal relationship.
These figures are limited to what the registry posts. The record does not provide event narratives, follow-up duration, or a comparison group, and it does not explain the reason for termination. Accordingly, the counts describe reported safety events in the study group but cannot establish how the event experience compares with another treatment or with the background risk in a similar population.
12. What the Result Does, and Does Not, Mean
The registry record establishes that NCT03812679 was a single-group evaluation of the AMIA APD Solution Generation System in patients with ESRD, with enrollment of 22 and a primary focus on chemical composition of generated dialysis solution. It describes sampling from the heater bag at Week 1, 4, 8 and 12 and a classification rule for whether a test met specifications. It also lists a secondary outcome concerning change from baseline in total Kt/Vurea.
It does not report the primary outcome percentages, test counts, evaluable denominators, secondary outcome values, or any statistical analyses. Consequently, the posted record does not show the observed chemical-composition results, the magnitude or precision of any change in Kt/Vurea, or whether results varied across visits. It cannot support a conclusion about how often the system-generated solution met specifications.
The study has no separate control group, and no masking is listed. This design is not a randomized comparison and cannot estimate a comparative effect against another device or treatment. The chemical reference specification is a benchmark for classifying solution samples; it is not a participant control group. The record also does not report a statistical analysis plan, missing-data methods, or the reason the study was terminated.
The safety record lists 3 participants affected by serious adverse events, 2 affected by other adverse events, and 0 deaths among the group of 22 at risk in each category. It includes three serious-event terms, each reported at 4.5%. These counts do not establish causality or comparative safety. Overall, the record describes the evaluation's design and intended measurements, but leaves the primary performance results and their statistical uncertainty unreported.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary endpoint is a measurement-based specification assessment rather than a randomized comparison of patient outcomes. Understanding such an endpoint depends on a clear definition of what counts as an observation, how an observation is classified, and which denominator is used. The registry describes a failure rule based on any measured value falling outside limits, but its wording alternates between percentages of tests and percentages of participants. That distinction affects the meaning of any resulting percentage.
The repeated assessment visits and multiple chemical test methods also create a need for transparent reporting of denominators and analysis choices. Readers need to know how many tests were evaluable at each visit, how repeated measurements from the same participant were handled, and whether multiple endpoints were interpreted with a planned strategy. Those details are not reported in the registry record, and no endpoint results or analyses are posted.
The single-group design sets a further boundary on interpretation. A comparison with a chemical specification can describe whether sampled solution met that benchmark, but it is different from a concurrent randomized comparison of clinical outcomes. The registry's planning assumptions describe equal allocation between two arms even though this evaluation is listed as single-group; these assumptions are an illustration and not evidence of the study's own design rationale or observed power.
Finally, the record illustrates why results and methods need to be read together. Enrollment and safety counts alone do not answer the primary performance question. With the study marked terminated and the reason not reported, readers also cannot determine from this record whether the planned assessments were completed. The absence of posted analyses leaves the statistical interpretation unresolved.
14. 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 important limitation of the registry record is that it does not report the primary chemical-composition results, despite describing the endpoint and its assessment visits. It also does not report the number of overall tests analyzed or evaluable tests at each timepoint, although it says these counts were captured. Without results and denominators, neither the frequency of meeting specifications nor its precision can be assessed.
The endpoint description uses both tests and participants as the basis for percentages. The record does not clarify which unit governs the posted outcome, how multiple tests per participant were handled, or whether results were summarized separately by chemical test method. It does not report the values defining the specification limits, so the assessment cannot be independently reconstructed from the registry description.
The single-group design has no concurrent control arm, and masking is listed as none. The registry does not report a statistical analysis plan, confidence intervals, analysis methods, missing-data handling, interim analyses, or adjustments for multiple methods and visits. The secondary Kt/Vurea outcome is named, but its results and analysis are not reported in the registry record.
The study is listed as terminated, but the reason is not reported in the registry record. It is also not clear whether all planned visits and measurements were completed. The posted safety counts lack event narratives, duration of follow-up, and causal assessments. These limitations restrict both the interpretation of the study's intended performance assessment and the safety information available from the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Performance Evaluation of the AMIA APD Solution Generation System in Patients End Stage Renal Disease (ESRD) — NCT03812679.
- Registry record last updated 2025-07-14; status last verified 2025-07.
- Results first posted 2021-02-05.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03812679 is a terminated, single-group device evaluation sponsored by Vantive Health LLC, with enrollment of 22. It concerns the AMIA APD Solution Generation System in patients with ESRD. The primary outcome is the percentage of tests meeting chemical-composition specifications at Week 1, 4, 8 and 12. The registry describes comparison with specifications for Baxter's approved low calcium Dianeal PD solution and lists nine test methods.
The registry lists change from baseline in total Kt/Vurea at Week 5, 6, 7, or 8 as a secondary outcome. It reports 3 participants affected by serious adverse events, 2 affected by other adverse events, and 0 deaths. The primary and secondary outcome results, analysis methods, reason for termination, and missing-data procedures are not reported in the registry record. The record lists zero analyses.