Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD (NCT05734989), a registered phase not stated study. The primary outcome is Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening.

2. Clinical Question

The study’s broader purpose is to examine ways to identify CKD risk and support screening, monitoring, and treatment provision. Aim 1 describes screening through community organizations and referral to a PCP. Aim 2 describes clinic-based implementation to assist PCPs with screening and treating patients with diabetes. These aims provide context for the primary endpoint, but the endpoint itself is narrower: it records whether participants in the specified group received uACR screening within the stated timeframe.

The registry record does not report a comparative result for the primary question. It therefore cannot establish from its posted results whether screening occurred more often in one group, or how large any difference might have been. The described aims and interventions should be distinguished from evidence of an outcome: the registry record identifies planned activities and a measured endpoint, but does not report an analysis of that endpoint.

3. Trial Design

NCT05734989 is a completed study sponsored by Duke University. The record gives an enrollment of 248 and describes two connected areas of work. Aim 1 uses community organizations to screen Hispanic/Latino(a)s for kidney disease, diabetes, and other risk factors, with referral to a PCP. Aim 2 concerns implementation in local health clinics to assist PCPs with screening and treating Hispanic and Black patients with diabetes. The summary says that the project’s eventual aim is to inform possible larger-scale implementation and to slow kidney disease progression; these are stated goals, not reported study findings.

The registry lists diagnostic tests for blood pressure and HbA1c, as well as behavioral guidance titled PCP Guidelines for Screening and Monitoring Hispanic/Latinx patients for CKD. It identifies a group of Hispanic/Latinx patients at risk for CKD and a group of PCPs caring for Hispanic Latinx patients who agree to use study guidelines and interventions. The outcome and safety records also use the labels Screening/Treatment Group and Optimal Care Group. These descriptions do not by themselves establish a randomized comparison, and the allocation method is not stated. The registry warns that the arms are not a like-for-like control comparison.

The study start date is 2023-05-18, and primary completion is recorded as 2025-04-04. The status is COMPLETED. Completion status does not mean that outcome analyses are posted: the registry lists four outcome measures but zero analyses. The record does not report a statistical analysis plan, the approach used to assign participants or clinics to groups, or a sample-size justification. Consequently, the design can be described from the stated aims, groups, and measures, but further design details should not be inferred.

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: Only relevant to the Hispanic/Latinx patients at risk for CKD group; 28 participants were lost to follow-up.

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 Number of Participants Who Received Urine Albumin-to-Creatinine Ratio (uACR) Screening, measured over Within three months of T0 (primary care appointment).

The primary endpoint counts participants who received a urine albumin-to-creatinine ratio (uACR) screening within three months of T0, where T0 is the primary care appointment. uACR is the specific screening measure named in the endpoint. The registry describes the outcome as a count of participants, rather than a reported estimate of the proportion screened or a comparison between groups.

The endpoint description restricts its population: it says the measure is not relevant to the Hispanic/Latinx patients at risk for CKD group. It also says that participants in the Screening/Treatment Group were included only if they had not already received a uACR. This eligibility detail matters when interpreting a count, because the endpoint is defined for a particular group and excludes people with prior screening from that group’s assessment. It should not be generalized to every participant described in the study.

As a general measurement concept, a screening endpoint can assess whether a specified clinical process occurred within a defined period. It does not, by itself, measure later kidney outcomes, the accuracy of screening, or whether a screening result led to treatment. The registry’s stated timeframe and endpoint definition identify what was intended to be counted, but the posted record does not report the count, a denominator for an outcome analysis, or a group comparison. Therefore, the measure’s result and its precision cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is described?

The endpoint is a count of participants who received uACR screening within the stated period. In general, a count records how many eligible people experienced or completed a specified event. It is not the same quantity as a proportion, because a proportion also requires a denominator that defines the eligible group. A count can be informative about the volume of activity, while a proportion can describe the share of a defined population with that activity. The registry names the count endpoint but does not post its result or an analysis denominator. No rate or proportion can be inferred from the endpoint title alone.

The distinction between a count and a group comparison is also important. A count for one group does not, by itself, show whether screening differed between groups. A comparison requires outcome information for the relevant groups and a clearly defined contrast. The posted record does not give analysis results for such a contrast. The labels Screening/Treatment Group and Optimal Care Group are descriptive labels in the registry; they do not provide an estimated treatment effect.

What does the timeframe contribute?

The endpoint specifies screening within three months of T0, which the record defines as the primary care appointment. In general, a timeframe makes an outcome more operational: it says which events count and when they must occur. It also narrows the interpretation. A measure tied to screening within a defined period does not capture screening outside that period, later health outcomes, or the clinical consequences of a positive or negative result unless those are separately measured and reported. The registry does not provide a primary endpoint result or additional details about how the timeframe was applied in the analysis.

Why does the eligible population matter?

The endpoint description excludes the Hispanic/Latinx patients at risk for CKD group from the measure and says that participants in the Screening/Treatment Group were included only if they had not already received uACR. This is part of the endpoint definition, not a minor qualification. In general, the meaning of an estimate depends on who was eligible to contribute data. An estimate restricted to people without a prior test would answer a different question from one calculated among all participants. The registry does not report the actual analysis population, participant flow, or how many eligible people contributed an endpoint result.

What would a confidence interval mean?

In general, a confidence interval expresses the uncertainty around an estimate under a specified statistical model and analysis procedure. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. It does not guarantee that the estimate is free of bias, nor does it account automatically for problems such as an inappropriate comparison group, incomplete outcome ascertainment, or departures from the analysis assumptions. No confidence interval is reported for the primary endpoint in the registry record, so its precision cannot be assessed.

A p-value is a measure of how compatible the observed data are with a specified null hypothesis under the model used. It does not measure the probability that the null hypothesis is true, nor does it describe the magnitude or importance of an effect. A p-value is not reported for this endpoint. More broadly, the record does not report endpoint estimates or analyses from which statistical significance could be evaluated.

Why does allocation affect interpretation?

In general, randomized allocation can help make comparison groups similar in expectation, while nonrandom allocation can leave differences between groups that also relate to the outcome. However, the allocation method for this study is not stated. The registry specifically cautions that the arms are not a like-for-like control comparison. This means that group labels alone should not be treated as evidence that observed differences, if any, would be attributable to the intervention. The record does not report an adjusted analysis or other strategy for addressing differences between groups.

What can be said about sample size and analysis choices?

The enrollment is 248, but enrollment alone does not show how many participants contributed to this endpoint or whether the study had adequate precision for a particular comparison. In general, sample-size planning depends on the outcome, the effect the study is designed to detect, variability or event frequency, the chosen error rates, allocation, and analysis method. The registry record does not report a sample-size justification or the assumptions used in any original design calculation. It also does not report an analysis plan, statistical model, covariate adjustment, interim analysis, or procedures for handling multiple outcomes. These details must not be inferred from the endpoint definition or completion status.

For binary event outcomes, general methods may compare event counts or event proportions, depending on the estimand and design. If outcomes are clustered within clinics or providers, methods may also need to account for within-cluster similarity; observations from one clinic may not behave like fully independent observations. The record describes community organizations, clinics, and PCPs, but does not state whether or how clustering was incorporated into an analysis. No statistical model can be attributed to this study from the posted record.

Over-dispersion is a general concern when the variability in count data is greater than a chosen model expects. Ignoring it can make uncertainty estimates too small and inference too confident. Whether over-dispersion is relevant depends on the data structure and model. The registry record does not report a count-data model or enough outcome information to assess this issue for the primary endpoint. These concepts explain possible analytical considerations; they are not claims about methods used in this study.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Screening/Treatment Group", "Optimal Care Group")
n      <- c(68, 92)
events <- c(40, 92)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Screening/Treatment Group  68  40  58.8  46.2  70.6  47.0  69.7  46.9  69.8
ARM  Optimal Care Group  92  92  100.0  96.1  100.0  96.0  100.0  96.1  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures but reports zero analyses. It does not report whether a primary analysis hierarchy was specified beyond identifying the uACR screening count as the primary endpoint, or whether adjustments for multiple comparisons were planned. In general, testing multiple outcomes or contrasts can increase the chance of finding at least one apparently notable result by chance. Prespecifying a primary outcome and a testing strategy can help clarify how results should be interpreted. The record does not provide enough information to determine what multiplicity procedures, if any, were used.

Missing-data methods are not reported in the registry record. The endpoint description identifies an eligibility restriction for participants with prior uACR screening, but it does not describe losses to follow-up, unavailable screening information, or how missing endpoint status was handled. In general, excluding participants with missing outcomes, treating them as not screened, or using a model-based approach can lead to different estimates and relies on different assumptions. No such approach can be attributed to this study from the posted record.

The analysis populations are also not described beyond the endpoint-specific statement that the Screening/Treatment Group included only participants who had not already received uACR. The registry does not report how many people met that definition, how many were analyzed, or whether analyses followed a predefined intention-to-treat or per-protocol population. These omissions limit assessment of selection, attrition, and the relationship between the enrolled population and the endpoint analysis. They should be read as unreported information, not as evidence that a particular method was or was not used.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The safety record lists three groups: Hispanic/Latinx Patients at Risk for CKD, Screening/Treatment Group, and Optimal Care Group. Their respective numbers at risk for serious adverse events are 59, 97, and 92. The corresponding numbers affected by serious adverse events are 0, 0, and 0. Deaths are recorded as 0 in each group. The record also lists the same group-specific numbers at risk for other adverse events—59, 97, and 92—with 0 affected in each group.

These figures describe what is entered in the registry safety record. They do not establish that no adverse events occurred outside the registry’s reporting definitions, that every participant had complete safety follow-up, or that the groups had comparable risk. The registry does not list serious adverse event terms. It also cautions that the arms are not a like-for-like control comparison, and allocation is not stated. Accordingly, the figures should not be read as a comparative safety estimate or as proof of safety. The posted record does not provide event-level detail, follow-up duration for safety, or an analysis of differences among groups.

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

The record establishes that NCT05734989 was marked COMPLETED and describes a study focused on screening and care for CKD risk in Hispanic/Latinx communities, with clinic-based work also involving Hispanic and Black patients with diabetes. It identifies uACR screening within three months of a primary care appointment as the primary endpoint and gives an eligibility restriction for that measure. These are useful details about the study question and how the outcome was defined.

The record does not establish whether the primary endpoint was achieved. No primary endpoint count, comparison, effect estimate, confidence interval, or analysis is posted. The number of enrolled participants does not replace those results, because enrollment does not tell how many eligible participants received screening or contributed endpoint data. The study’s stated goal of informing later implementation and slowing CKD progression is a project aim, not a finding about those outcomes.

Nor does the registry record support a causal claim that the listed guidance or screening activities changed care. Allocation is not stated, and the record warns that the arms are not a like-for-like control comparison. Without outcome estimates and relevant design and analysis details, any group difference cannot be attributed to an intervention. No inference about kidney disease progression can be made from the primary screening endpoint alone.

In general, a completed study can still have results that are not posted in a registry record. That distinction matters: absence of posted results does not mean that no data were collected, but it also does not permit conclusions about effects or precision. The appropriate reading is limited to the stated study design features, endpoint definition, and recorded safety figures. Whether screening, treatment provision, or health outcomes differed remains unreported in the registry record.

14. Why This Trial Matters Statistically

This study raises a practical statistical question: how to define and evaluate a screening process within community and primary care settings. The primary endpoint is specific about the test, the time window, and the relevant group. Those details are essential to reproducible measurement. Without a defined endpoint population and timeframe, a screening count could represent different activities across groups or settings. The record’s restriction to Screening/Treatment Group participants who had not already received uACR also illustrates why eligibility definitions are central to interpreting a process measure.

The registry also illustrates why a study’s implementation context and its statistical comparison must be considered separately. The summary describes community organizations, clinics, PCPs, and distinct patient populations. Such settings can be important to understanding how an intervention is delivered, but they may also create dependencies among observations or differences among groups. General statistical methods must match the design and data structure; the registry record does not say how those features were handled.

Transparent reporting is essential to judging evidence. The record identifies an endpoint and marks the study completed, but reports zero analyses. Without outcome estimates and their uncertainty, readers cannot assess the observed screening level, compare groups, or evaluate precision. The missing analysis details also prevent review of multiplicity, missing data, and the populations included in the analysis. This is not a negative result; it is a limit on what the posted record can establish.

The broader statistical lesson is that a well-defined research aim is only one part of an interpretable result. A clear comparison, complete outcome reporting, and an account of uncertainty are also needed. The record allows readers to understand what the investigators sought to study, while leaving the effectiveness and comparative interpretation unanswered.

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.

Several limitations specific to interpretation arise from the registry record. First, although it identifies uACR screening as the primary endpoint, it does not report the outcome count or any statistical analysis. The number of participants enrolled cannot establish the number screened, the rate of screening, or the precision of a comparison. The record lists four outcome measures but zero analyses.

Second, the endpoint applies to a restricted population. It is described as not relevant to the Hispanic/Latinx patients at risk for CKD group and applies only to Screening/Treatment Group participants who had not already received uACR. The record does not report the size of this eligible analysis population, its outcome denominator, or participant flow. That makes the representativeness and completeness of endpoint ascertainment difficult to assess.

Third, allocation is not stated, and the record explicitly warns that the arms are not a like-for-like control comparison. This limits any interpretation of group differences as intervention effects. The record does not describe baseline comparability, adjustment, clustering by clinic or provider, or other strategies that might address group differences.

Finally, the registry record does not report the statistical analysis plan, missing-data methods, multiplicity strategy, sample-size justification, or interim analyses. These absences do not prove that such methods were not considered or used, but they prevent readers from evaluating them. The posted safety figures include zero affected participants in the listed groups, but event terms and safety analyses are not reported. These limitations concern what can be assessed from the registry record; they are not conclusions about unreported study conduct.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD — NCT05734989.
• Registry record last updated 2026-04-24; status last verified 2025-03.
• Results first posted 2026-04-24.
• 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

NCT05734989, titled Improving Screening and Therapy for Hispanic/Latinx at Risk for CKD, is sponsored by Duke University and is listed as COMPLETED. The record gives enrollment as 248, a study start date of 2023-05-18, and primary completion on 2025-04-04. Its aims describe community screening and referral, plus clinic-based support for PCP screening and treatment.

The primary endpoint counts participants receiving uACR screening within three months of T0, the primary care appointment. The endpoint description restricts the relevant group and excludes Screening/Treatment Group participants who had already received uACR. The registry lists four outcome measures and zero analyses; no primary endpoint result or statistical analysis is reported. Allocation is not stated, and the registry cautions that the arms are not a like-for-like control comparison. Safety records list 0 serious adverse events and 0 deaths in each of the three named groups.