Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO) (NCT01438710), a non-randomized phase 3 study. The primary outcome is Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro..

2. Clinical Question

The study’s clinical question is framed around a change in a measured symptom after conversion, rather than a randomized comparison of two independently assigned treatments. The registry summary describes stable kidney transplant subjects on Prograf or generic tacrolimus at baseline, followed by evaluation after conversion to LCP-Tacro. That before-and-after framing is important: the available record does not establish that any groups were formed through random assignment, and it explicitly identifies the allocation as non-randomized.

The primary outcome is a score of overall hand tremor severity. A numerical result would be needed to determine the direction and size of the mean change. Precision would also matter: without a confidence interval, standard error, or other uncertainty measure for the change, readers cannot judge how precisely it was estimated. Those numerical results are not reported in the registry record. The clinical question can therefore be described, but the registry entries do not support a conclusion about the observed change.

3. Trial Design

STRATO is a completed Phase 3 study of switching kidney transplant patients with tremor to LCP-Tacro. The registry lists non-randomized allocation, no masking, and a parallel model. These design labels describe the recorded study structure; they do not establish a randomized treatment comparison. The registry enrollment is 44 participants.

The registry describes LCP-Tacro as tablets for once-daily oral administration and Prograf as tacrolimus capsules for twice-daily oral administration. Its brief summary characterizes participants as stable kidney transplant subjects taking Prograf or generic tacrolimus maintenance therapy before conversion. The primary efficacy description focuses on the change from baseline at Day 7 to the assessment at Day 14, seven days after conversion to LCP-Tacro. The record does not provide enough information to reconstruct all visit procedures, allocation details, or the exact analysis model.

Forty participants completed the study period, and 38 were evaluable for efficacy and included in the modified intention-to-treat population. The record does not explain why the remaining enrolled participants did not complete the study period, why two completers were not evaluable for efficacy, or how missing outcome measurements were handled. These details are not reported in the registry record.

The recorded study start is 2011-12, and primary completion is recorded as 2012-08. The registry status is completed. The sponsor is Veloxis Pharmaceuticals. These administrative details identify the study record but do not supply the efficacy estimates or the statistical methods needed to interpret their uncertainty.

Because allocation was non-randomized and masking was absent, observed differences between the listed treatment groups should not automatically be attributed to treatment. The record does not report a randomized control comparison or enough detail to assess how baseline characteristics, treatment history, or other factors were addressed. The study’s central efficacy endpoint is instead described as a change from baseline after conversion. How that change was estimated and tested is 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.

First Week of Treatment

Second Week of Treatment

Analysis population for the primary outcome, as defined in the registry: Of the 40 patients who completed the study period, 38 patients were evaluable for efficacy evaluation and included in the modified intention to treat (mITT) population. The outcome measure is given as total score below.

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: 44 patients started on the initial one-week treatment on Prograf and 41 were switched to the one-week LCP-Tacro treatment. 40 patients completed the one-week treatment on LCP-Tacro and continued into the 24-months extended use period.

6. Primary Endpoint

The registry lists the primary outcome as Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro., measured over 14 days.

The primary endpoint is the mean change from baseline in the Fahn-Tolosa-Marin Clinical Rating Scale (FTM) overall tremor score. Baseline is identified as Day 7, and the post-conversion assessment is Day 14, seven days after conversion to LCP-Tacro. The overall score ranges from 0 to 100; higher scores denote worse or more severe tremor. The outcome is a continuous measure, and the registry identifies the reported summary format as a mean with standard deviation.

A continuous score can capture degrees of symptom severity rather than reducing each participant’s experience to a yes-or-no classification. A change score expresses how the measured outcome differs from its baseline value. In general, this can be useful when the question concerns whether a measured symptom changes after an intervention. The mean describes the average score or average change in a group, while the standard deviation describes how spread out individual scores are around that mean. These are distinct summaries: a mean change alone does not show whether participants had similar or widely varying changes.

The registry description says that the total score, standard deviation for each treatment, and mean change are given, but the numerical values are not reported in the registry record available for interpretation. Nor are a confidence interval, a test statistic, or a p-value for the primary endpoint reported. The direction, magnitude, and precision of the observed mean change therefore cannot be evaluated from the registry entries.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is an overall tremor score on the Fahn-Tolosa-Marin Clinical Rating Scale. The registry describes the endpoint as a mean change from baseline at Day 7 to Day 14, seven days after conversion. It also identifies the mean and standard deviation as the summaries for each treatment. The numerical summaries and the statistical analysis used to obtain them are not reported in the registry record.

What does a mean change represent?

In general, a change score is calculated for each participant by comparing a later measurement with that participant’s baseline measurement. The group mean change then describes the average of those individual changes. This answers a different question from comparing two group means measured at a single time: it focuses on how scores changed over time within the assessment framework. The registry states that the endpoint is a mean change, but does not describe the precise calculation or analysis model. It is therefore not possible to verify whether the reported estimate, if available, was adjusted for other variables or calculated using a particular repeated-measures method.

The scale ranges from 0 to 100, and higher values mean more severe tremor. A negative change would generally indicate a lower follow-up score relative to baseline, while a positive change would generally indicate a higher score; this is a general explanation of change-score direction, not a claim about STRATO’s result. Since the actual mean change is not reported in the registry record, its direction cannot be stated.

What does the standard deviation tell readers?

In general, the standard deviation describes the spread of individual observations around a mean. It is not the same as the uncertainty around the mean. A group may have a broad spread of participant scores while the estimated mean is relatively precise if the study has enough information; conversely, a mean can be uncertain even when individual scores are not extremely dispersed. The registry’s endpoint description says standard deviations are reported, but their values are not reported in the registry record available for this interpretation.

Why would a confidence interval matter?

In general, a confidence interval conveys uncertainty around an estimate by giving a range of values compatible with the data and the method used. Its width helps readers assess precision, while its location indicates the range of plausible directions and magnitudes. It is not a guarantee that the true value lies in a particular interval. No confidence interval for the mean change is reported in the registry record. A p-value is also not reported. Without these quantities and the underlying endpoint estimates, the strength of statistical evidence cannot be evaluated.

Why does allocation matter?

The registry lists the study as non-randomized, unmasked, and parallel. In general, random allocation can help balance measured and unmeasured participant characteristics between treatment groups, while masking can reduce some forms of assessment or performance bias. Those protections cannot be presumed for this study. The registry does not report enough detail to establish how participants came to be in each treatment group, what safeguards were used, or how potential confounding was handled. As a result, a difference between groups, if reported, would not automatically be interpretable as a causal treatment effect.

The primary endpoint description is also framed around change from baseline after conversion. In general, using the same participants’ baseline and follow-up measurements can account for some stable differences between individuals, but it does not rule out time-related changes, measurement effects, or other influences. The registry does not specify the statistical model for repeated measurements or whether the endpoint was analyzed as paired data. Any claim about such choices would be speculation.

What are the sample-size illustrations?

The planning illustration described for this study uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It is based on a fraction of the observed effect. These are planning assumptions for illustrative calculations, not a description of the trial’s original design or observed power. The registry record does not report the trial’s own sample-size justification, nor does it provide the observed numerical effect needed to interpret effect-based planning scenarios. The calculations should not be treated as evidence about the probability that the study detected an effect.

In general, power is a design-stage probability tied to assumptions about the effect, variability, significance threshold, and analysis. It is not a post-study measure of whether a finding is true. Illustrative sample sizes based on an observed effect are planning exercises and should not be confused with the number of participants actually enrolled or analyzed. The record’s enrollment is 44, but that fact alone does not reveal the rationale for choosing the study size or whether the intended precision was achieved.

Why can over-dispersion matter?

In general, over-dispersion means that observed variability is greater than a model assumes. When a model underestimates variability, uncertainty estimates can be too small and statistical evidence can appear stronger than warranted. This concept is relevant to count-based outcomes or other data whose variance structure does not match the assumed model. STRATO’s primary endpoint is described as a continuous score, and the registry does not report the model or diagnostics used. There is no basis in the registry entries to say that over-dispersion occurred in this trial or affected its findings.

These concepts clarify what would be needed to interpret the primary endpoint: the numerical mean change, an appropriate measure of uncertainty, and enough information about the analysis and study conduct to assess bias and assumptions. Those details are not reported in the registry record. Statistical concepts can explain how such results would ordinarily be read, but cannot substitute for the missing estimates.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one outcome measure and one analysis. It does not report whether there were additional planned endpoints, subgroup analyses, repeated statistical tests, or interim analyses beyond those counts. A multiplicity-adjustment plan is not reported in the registry record. It is therefore not possible to assess whether testing across several outcomes or analyses was considered or controlled.

For the primary efficacy population, 40 participants completed the study period and 38 were evaluable for efficacy and included in the modified intention-to-treat population. The record does not say why the two groups of counts differ, identify the participants excluded from efficacy evaluation, or explain how incomplete measurements were treated. Reasons for non-completion among the 44 enrolled participants are not reported in the registry record.

In general, missing data can affect an estimate when the likelihood or pattern of missingness is related to participants’ outcomes or characteristics. Different analysis strategies make different assumptions about unobserved values. The registry does not report a missing-data strategy, sensitivity analyses, imputation methods, or how participants with unavailable measurements were handled. No assumption about those procedures can be made from the counts alone.

The term modified intention-to-treat identifies the efficacy population label, but the record does not define the modification or explain the criteria for inclusion. It also does not report whether all evaluable participants contributed measurements at both time points. Consequently, the potential effect of exclusions or missing measurements on the primary estimate cannot be judged. The numerical primary outcome itself is not reported in the registry record, which further limits assessment of robustness.

11. 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: incision site cellulitis (2.3%).

The registry lists serious adverse events for participants at risk in each named group. For LCP-Tacro, 0 serious adverse events are listed among 41 participants at risk. For Prograf, 1 serious adverse event is listed among 44 participants at risk. These are reported counts, not estimates of a causal treatment effect. Given the non-randomized allocation, they should not be interpreted as a randomized comparison of safety.

For other adverse events, the registry lists 2 among 41 participants at risk in the LCP-Tacro group and 7 among 44 participants at risk in the Prograf group. The record does not provide event-level details for those counts in the registry record for interpretation. The listed top serious-event term is Incision Site Cellulitis, with 2.3%; the record does not establish in the registry record which group that term is attributed to. Death counts are not reported in the registry record, so they should not be interpreted as zero.

In general, adverse-event counts need context: which events were collected, how they were defined, whether participants could contribute more than one event, and the duration of observation. The registry gives a 14-day primary endpoint timeframe but does not establish that this was the full safety observation period. These figures describe the posted counts and do not, by themselves, establish whether an event was caused by treatment or whether group risks differ.

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

The registry record establishes that STRATO examined hand tremor in stable kidney transplant patients receiving Prograf or generic tacrolimus maintenance therapy, with assessment after conversion to LCP-Tacro. It identifies the primary outcome as mean change in the Fahn-Tolosa-Marin Clinical Rating Scale overall tremor score from baseline at Day 7 to Day 14. It also states that higher scores on the 0-to-100 scale denote more severe tremor.

The numerical result is not reported in the registry record. The baseline and follow-up means, standard deviations, and mean change are not available in the registry record for interpretation. No confidence interval or p-value is reported. Accordingly, the direction and size of the observed change, and how precisely it was estimated, cannot be stated. The endpoint definition alone is not evidence of the outcome.

The study enrolled 44 participants, 40 completed the study period, and 38 were evaluable for efficacy. Those counts describe enrollment and analysis populations, not the magnitude or reliability of an outcome. Reasons for the differences among those counts and the approach to missing measurements are not reported in the registry record.

The study was non-randomized and unmasked. In general, an observed before-and-after change can be influenced by factors other than the intervention, and a non-randomized design does not provide the same basis for causal inference as random assignment. The record does not provide sufficient analysis details to evaluate possible confounding or other biases. The efficacy result itself is absent, so even a descriptive statement about the measured change is not possible.

The reported safety counts are limited descriptive information. They do not establish comparative safety or causation, and the death counts are not reported in the registry record. Taken together, the registry entries permit a description of the research question, design labels, population counts, endpoint, and selected adverse-event counts. They do not support a claim that LCP-Tacro improved, worsened, or had no effect on tremor, nor do they establish that a treatment caused or prevented an adverse event.

13. Why This Trial Matters Statistically

This study raises several statistical interpretation issues that are important in clinical research. First, the primary question concerns change in a continuous symptom score after conversion. For such an endpoint, the average change is only part of the result: variability among participants and uncertainty around the mean are also necessary to understand how stable and precise the estimate is. The registry describes the intended summaries but does not report their numerical values.

Second, the record identifies non-randomized allocation and no masking. Those features matter because treatment groups may differ for reasons unrelated to treatment, and assessments may be vulnerable to knowledge of treatment. A before-and-after outcome can be useful descriptively, but it does not by itself separate an intervention-associated change from time effects or other influences. The available record does not describe adjustment methods or procedures that would address these concerns.

Third, the efficacy population is smaller than the enrollment count. Forty participants completed the study period, and 38 were evaluable for efficacy. The record does not explain the exclusions or missing-data methods. Statistical interpretation depends not just on how many participants entered a study, but on who contributed endpoint data and how incomplete observations were handled.

Finally, planning calculations and observed results answer different questions. The stated sample-size illustration uses assumptions and an effect-based planning approach; it is not the trial’s own design justification and is not observed power. Because the numerical observed effect is not reported in the registry record, the planning illustration cannot be independently interpreted from these registry entries. STRATO therefore provides a clear example of why endpoint definitions and design labels are not enough: numerical estimates, uncertainty, analysis details, and transparent accounting of participants are all needed for a complete statistical reading.

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 direct limitation for interpreting efficacy is that the numerical primary outcome is not reported in the registry record. Although the outcome description refers to mean scores, standard deviations, and mean change, none of those values is available. Confidence intervals and p-values are also not reported. The magnitude, direction, and precision of the primary result therefore cannot be assessed.

The registry identifies a non-randomized design with no masking. This limits the strength of causal interpretation and raises the possibility of differences between groups or influences on assessment that the available record cannot evaluate. Although the endpoint is framed as change after conversion, the statistical model and the handling of repeated measurements are not reported in the registry record.

The analysis population requires further explanation. Of 44 enrolled participants, 40 completed the study period and 38 were evaluable for efficacy. The record does not state why participants did not complete or why some completers were not included in the efficacy population. It does not describe missing-data methods or sensitivity analyses. The impact of these population differences on the estimated endpoint is therefore unknown.

Additional protocol and analysis details are not reported in the registry record, including the sample-size justification, interim-analysis procedures, the statistical plan, and any multiplicity strategy. The registry entries available also do not specify the full safety observation period or provide a detailed account of adverse events. The serious-event term listed with 2.3% is not linked to a group in the registry entries. These omissions constrain interpretation of efficacy and safety and do not permit reconstruction of the study’s complete analysis.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO) — NCT01438710.
• Registry record last updated 2015-10-01; status last verified 2015-09.
• Results first posted 2015-05-08.
• 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.

18. Record Summary

STRATO (NCT01438710) is a completed Phase 3, non-randomized, unmasked, parallel study sponsored by Veloxis Pharmaceuticals. The registry records a study start of 2011-12, primary completion in 2012-08, and enrollment of 44 participants.

The study examined hand tremor in stable kidney transplant patients receiving Prograf or generic tacrolimus maintenance therapy before conversion to once-daily oral LCP-Tacro. The primary endpoint was mean change in the Fahn-Tolosa-Marin overall tremor score from baseline at Day 7 to Day 14. The scale ranges from 0 to 100, with higher scores indicating more severe tremor.

Forty participants completed the study period, and 38 were evaluable for efficacy. The registry record does not report the numerical primary efficacy estimates, their uncertainty, or the reasons for differences between enrollment and analysis counts. It lists 0 serious adverse events among 41 participants at risk in the LCP-Tacro group and 1 among 44 at risk in the Prograf group; death counts are not reported in the registry record.