A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients. (NCT00758602), a randomized phase 4 study. The primary outcome is Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation.

2. Clinical Question

3. Trial Design

This was a randomized, open-label, parallel-group Phase 4 study of MMF combined with tacrolimus and corticosteroids in kidney-transplant patients. The registry lists a planned enrollment of 210 and a completed status. The recorded start was 2008-09, and the primary completion was 2011-02. The anticipated time on study treatment was 1 year. The sponsor was Hoffmann-La Roche.

Participants were assigned to one of two regimens: MMF with standard-dose tacrolimus and corticosteroids, or MMF with low-dose tacrolimus and corticosteroids. The brief description gives target tacrolimus levels for the regimens, while the arm descriptions contain additional dosing information. The standard-dose regimen was described as targeting 10-12 ng/mL before maintenance at 8-10 ng/mL. The low-dose regimen was described as targeting 8-10 ng/mL initially, then 3-7 ng/mL in month 3, followed by maintenance at 3-5 ng/mL. The registry record does not report the original statistical design assumptions or the rationale for the planned enrollment.

The primary outcome was CADI score at month 12 after transplantation. The primary analysis included participants with a biopsy-confirmed CADI assessment at that time. The posted group sizes for this endpoint were 57 in the standard-dose group and 52 in the low-dose group, rather than the full trial enrollment. Other outcome analyses used different group sizes; for example, the posted safety groups contained 104 and 106 participants. The registry record does not report a complete account of why participant counts differ across outcomes.

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: ITT population; only participants with biopsy confirmed CADI assessment 12 months post-transplantation were included in the analysis.

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: Intent-to-Treat (ITT) population: all randomized patients who received at least one dose ofthe treatment-group specific medication.

6. Primary Endpoint

The registry lists the primary outcome as Chronic Allograft Damage Index (CADI) Score at Month 12 After Transplantation, measured over Month 12.

The primary endpoint was the Chronic Allograft Damage Index (CADI) score at month 12 after transplantation. CADI combines scores across six biopsy-based histological categories: interstitial inflammatory cell infiltration, interstitial fibrosis, tubular atrophy, mesangial matrix proliferation, glomerular sclerosis, and endothelial proliferation. Each category is scored according to the extent of the finding, and the CADI score is the sum of the six category scores. The registry describes the endpoint as a mean on a score scale, with standard deviation as the measure of spread.

A composite histological score can provide a way to describe several aspects of tissue findings with one outcome. In general, this can be useful when the clinical question concerns the overall pattern of tissue changes rather than a single feature. Because the score is constructed from ordered category ratings, a difference in means describes an average contrast in the composite score; it does not, by itself, specify which individual histological feature accounts for the contrast.

The endpoint is limited to participants with a biopsy-confirmed assessment at month 12. The registry record does not report a minimum clinically important difference, a threshold separating low from high risk, or how missing month-12 biopsy assessments were handled. Those details matter when translating a numerical score difference into clinical interpretation.

7. Results Posted in the Registry

• MMF, Low Dose Tacrolimus: mean 2.13 versus 1.82 on control; difference 0.31 (95% CI -0.44 to 1.06), standardized effect d = 0.16; z-test p = 0.416.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Time to First Acute Rejection Post-Transplant - Number of Participants With an Event

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • MMF, Low Dose Tacrolimus: 3.8% (4/106) versus 1.9% (2/104) on control; risk difference 1.9 percentage points (95% CI -2.6 to 6.3), risk ratio 1.96 (0.37–10.48); unadjusted two-proportion z-test p = 0.421.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MMF, Low Dose Tacrolimus and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Treatment Failure at 12 Months Post-Transplant

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • MMF, Low Dose Tacrolimus: 6.6% (7/106) versus 9.6% (10/104) on control; risk difference -3.0 percentage points (95% CI -10.4 to 4.4), risk ratio 0.69 (0.27–1.74); unadjusted two-proportion z-test p = 0.424.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between MMF, Low Dose Tacrolimus and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists seven secondary outcomes, including rejection-related outcomes, treatment failure, survival, serum creatinine, and GFR. Numeric results available in the record describe selected outcomes; the other listed secondary outcomes' results are not reported in the registry record. Across the secondary findings with numeric results, the estimates are uncertain and do not present a uniformly precise pattern that resolves the uncertainty in the primary CADI comparison.

Secondary outcomes answer related but distinct questions. Rejection events and treatment failure are not interchangeable with the primary biopsy-based score, and a result on one does not determine the result on another. Their role is to add context about the outcomes tracked in the study, not to replace the primary endpoint. The primary analysis concerns mean CADI score among people with a qualifying biopsy assessment, whereas secondary outcome analyses may involve other populations and time points.

Multiple outcomes create multiple opportunities for apparently notable findings to arise by chance. Unless a multiplicity procedure is prespecified and applied, unadjusted secondary p-values should generally carry less weight than a single primary test. The registry record does not report whether secondary analyses were adjusted for multiple comparisons or how they were prioritized. The posted secondary findings are therefore best treated as exploratory context rather than a set of independent confirmations of the primary result. The registry record also does not report results for every secondary outcome named in the study, limiting any overall assessment of the secondary outcome pattern.

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

• Percentage of Participants Experiencing Acute Rejection, Graft Loss, or Death at 6 and 12 Months Post-Transplant
• Time to First Acute Rejection Post-Transplant - Number of Participants With an Event
• Time to First Acute Rejection Post-Transplant
• Percentage of Participants With Treatment Failure at 12 Months Post-Transplant
• Participant and Graft Survival
• Serum Creatinine (Micromoles Per Liter [µmol/L])
• Glomerular Filtration Rate (GFR) (mL/Min)

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean difference describe?

For a continuous outcome such as CADI score, a mean difference compares the average score in one group with the average in the other. The recalculation uses the posted means of 2.13 for the low-dose group and 1.82 for the standard-dose group, and reports the contrast as low dose minus standard dose. A positive estimate therefore means the observed average was higher in the low-dose group. It does not mean that every participant had a higher score, and it does not describe the distribution of individual changes.

The recalculated contrast is unadjusted: it is derived from the posted summary statistics rather than from a model controlling for baseline or other participant characteristics. The posted group standard deviations, 2.0 and 1.974, describe variation among participants around each group mean. The recalculation uses a pooled standard deviation of 1.986 to characterize the variability for the comparison. This is a summary of spread, not an estimate of a treatment effect.

What does a confidence interval tell the reader?

A confidence interval expresses the uncertainty associated with an estimated contrast under the assumptions of the analysis. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. For this primary comparison, the recalculated interval includes zero, the value corresponding to no difference in group means. The interval also includes values on both sides of zero, so the estimate does not pin down the direction with high precision. An interval should be read as a range of estimates compatible with the data and analysis, not as a guarantee that the true effect lies within the endpoints.

The registry's ANCOVA result also has a 95% confidence interval that includes zero. ANCOVA is a regression-based method that compares groups while adjusting for specified covariates. In general, adjustment can account for measured variables included in the model and may change the estimated contrast or its precision. The registry record does not report the covariates or model details, so it is not possible to explain why the adjusted estimate differs from the unadjusted recalculation.

How should the p-values be read?

A p-value assesses how unusual the observed data, or data more extreme, would be under a specified null model. It is not the probability that the null hypothesis is true, and it does not measure clinical importance. The unadjusted primary comparison has p = 0.416; the reported ANCOVA analysis has p = 0.081. Both results are consistent with uncertainty about the group contrast. Neither p-value establishes that the groups are equivalent, nor does either reveal the probability that a future study will find a particular result.

The recalculated p-value is based on a simple unadjusted comparison from summary statistics. It is not a replacement for the trial's reported analysis. The ANCOVA result represents the sponsor's reported adjusted analysis, while the recalculation offers a transparent summary-statistic comparison. The registry record does not report enough modeling detail to reproduce the ANCOVA.

Why can participant counts differ?

The primary CADI analysis includes only participants with a biopsy-confirmed month-12 assessment. Its group sizes are 57 and 52. By contrast, the registry posts safety group sizes of 104 and 106, and some secondary outcomes use those larger denominators. Different outcomes can have different analysis populations because an assessment may only be available for a subset. The registry record does not report a detailed account of the missing assessments, whether any imputation was used, or how the primary analysis addressed missing data. The ITT label is accompanied by the explicit restriction to participants with a qualifying biopsy assessment, so the reported CADI means should not be assumed to represent every randomized participant.

What is the role of dispersion and over-dispersion?

Standard deviation describes how much individual scores vary around a mean. For a continuous measure, a larger spread generally makes a group contrast less precise when sample sizes are held fixed. Over-dispersion is mainly a concern in count or binary modeling when the observed variation exceeds what a chosen probability model expects; it can make standard errors too small if ignored. The primary CADI endpoint is analyzed as a continuous score with means and standard deviations, and the registry record does not report an over-dispersion assessment. The concept should not be used to infer an unreported problem in this trial.

For binary secondary outcomes, event counts and denominators describe observed frequencies. Their estimates can be uncertain when events are few. The registry also reports a Fisher Exact test for treatment failure, a method commonly used for categorical data when sparse counts may make large-sample approximations less suitable. The registry record does not report a broader statistical analysis plan or specify whether other secondary tests were adjusted for multiplicity.

How should the analyses be distinguished?

The recalculated primary comparison is a simple, unadjusted contrast from the posted group means, standard deviations, and sample sizes. It should be read as a check on the aggregate summaries, not as the study's full analysis. The registry's ANCOVA is the reported adjusted analysis. The registry record states no discrepancy between the recalculation and reported analysis, but the estimates are not numerically identical because the approaches differ. A valid interpretation keeps the analysis method, population, and endpoint attached to each estimate rather than treating them as interchangeable.

11. Confidence Intervals and Precision

The recalculated primary mean difference is 0.31 CADI points, with the comparison defined as low-dose minus standard-dose tacrolimus. Its 95% confidence interval crosses zero, extending from a negative value to a positive value, and the unadjusted p-value is 0.416. This span means the summary data do not estimate the contrast precisely enough to exclude no difference or to establish a single direction. The group standard deviations are close to 2 points, while the analyzed groups contain 57 and 52 participants.

The registry's adjusted ANCOVA estimate is 0.658, with a 95% confidence interval from -0.08 to 1.40. This interval also crosses zero. Its endpoints describe a range of adjusted contrasts compatible with the reported model and data; they do not establish that the groups are equivalent, nor do they identify which values are clinically important. The registry record does not provide a clinical importance threshold for CADI.

The distinction between precision and statistical significance is important. A confidence interval that includes zero signals uncertainty about whether the contrast is positive or negative under the relevant analysis. It does not demonstrate that the true contrast is exactly zero. Conversely, a point estimate alone should not be treated as a precise description of the effect. The primary analysis also relies on the biopsy-assessed subset, and the registry record does not report how missing month-12 assessments were handled. This limits what can be inferred about precision for the full randomized population.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning illustrations translate observed effects into hypothetical sample-size requirements under stated assumptions. For the continuous CADI comparison, the estimates are participants per arm. The illustration uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers detecting the observed effect and smaller fractions of that effect. The trial's own original design assumptions and sample-size justification are not reported in the registry record; these planning figures are not a reconstruction of the original design.

At 100% of the observed CADI effect, the illustration gives 645 participants per arm for 80% power and 863 participants per arm for 90% power. At 75% of the observed effect, it gives 1,146 participants per arm for 80% power and 1,535 participants per arm for 90% power. At 50% of the observed effect, it gives 2,579 participants per arm for 80% power and 3,452 participants per arm for 90% power. Smaller effects require more participants under these assumptions because they are harder to distinguish from random variation.

In plain language, 80% power refers to the chance of detecting an effect of the specified size if that effect were the true effect and the planning assumptions held. The 90% column uses a higher target chance of detection, which generally requires a larger sample. These are planning illustrations based on the observed effect, not observed power. They should not be read as evidence about the chance that the completed trial did or did not detect a treatment effect.

The secondary time-to-event planning figures use a different convention: they give total events, not participants per arm, and use a Schoenfeld approach. Other secondary planning figures give participants per arm. Thus, the unit depends on the endpoint. The planning assumptions and effect fractions are illustrative; the original sample-size calculation, if any, is not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.310; pooled standard deviation σ = 1.986.
2. n = 2 × (1.96 + 0.842)² × 1.986² / 0.310² = 644.6, rounded up to 645 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.31                      # observed difference in means
sigma <- 1.98643496944916                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(758602)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 645 (80% power), 863 (90% power)
 75% of observed effect: n per arm = 1,146 (80% power), 1,535 (90% power)
 50% of observed effect: n per arm = 2,579 (80% power), 3,452 (90% power)
power.t.test: 645.5 
Simulated power at n = 645 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor's primary analysis as an ANCOVA comparison of least-squares means. The reported difference was 0.658, with a 95% confidence interval from -0.08 to 1.40 and p = 0.081. This is an adjusted analysis, although the registry record does not identify the covariates or give enough detail to reproduce the model.

The recalculation from the posted group summaries is unadjusted. It gives a low-dose minus standard-dose mean difference of 0.31, with a 95% confidence interval that spans negative and positive values and an unadjusted p-value of 0.416. The difference between these estimates is not, by itself, evidence of an error: adjustment and unadjusted comparison can yield different estimates, especially when they use different modeling assumptions. The analysis population and missing-data handling are also relevant, and the registry record does not give enough information to evaluate those details fully.

The record does not flag a discrepancy between the sponsor analysis and the recalculation. The sponsor's reported ANCOVA remains the trial's own analysis, while the recalculation is a simple comparison of posted summaries. Both estimates have confidence intervals that include zero, so neither supplies a precise estimate establishing the direction of the primary group contrast.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary CADI endpoint and lists seven secondary outcomes. The posted information includes a reported ANCOVA analysis for the primary outcome and a Fisher Exact analysis for treatment failure. A comprehensive statistical analysis plan, including the prespecified hierarchy of tests or a family-wise error strategy, is not reported in the registry record. It is therefore unclear whether the secondary hypotheses were intended to be confirmatory, how their p-values were to be interpreted together, or whether adjustments for multiple comparisons were planned.

When several outcomes are examined, the chance of at least one apparently unusual result can increase if each is tested separately without adjustment. This general concern is why unadjusted secondary results warrant caution. It does not imply that any particular posted finding is false; rather, it limits the strength of conclusions that can be drawn from isolated secondary tests. The registry record does not report interim analyses or stopping rules, so none should be inferred.

The primary outcome population is described as ITT, restricted to participants with a biopsy-confirmed CADI assessment at month 12. This restriction means that the primary estimate is based on the biopsy-assessed subset. The registry record does not report how many participants lacked the assessment for each reason, whether missing outcomes were imputed, or whether sensitivity analyses assessed the effect of missingness. It also does not report whether the primary analysis included all randomized participants in any alternative approach.

These omissions matter because missing outcome data can affect both the estimated contrast and its uncertainty, depending on why observations are missing and how the analysis handles them. The posted results should therefore be interpreted as applying to the analyzed population as described, without assuming that missing assessments were random or that a particular imputation method was used. Details about allocation concealment, stratification, protocol deviations, and analysis-set definitions beyond the stated population are not reported in the registry record.

16. 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 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: acute rejection (1.0%), sudden death (0.9%), transplanted renal rupture (0.9%), urethral obstruction (0.9%), cytomegalovirus (cmv) disease (0.9%).

The registry posts safety denominators of 104 participants in the standard-dose group and 106 in the low-dose group. Serious adverse events were reported for 1 participant in the standard-dose group and 5 in the low-dose group. Other adverse events were reported for 33 and 37 participants, respectively. These are participant counts, and they describe the posted safety groups; they do not establish that the treatment assignment caused an event.

The listed serious-event terms include acute rejection at 1.0%, and sudden death, transplanted renal rupture, urethral obstruction, and cytomegalovirus (CMV) disease at 0.9% each. The registry record does not provide enough detail in this information to determine whether these terms overlap within participants, how events were attributed, or what event-specific denominators were used. Death counts by group are not reported in the registry record.

Safety counts should be interpreted alongside the study's follow-up and event definitions, which are not fully described in the available registry information. A difference in observed counts is descriptive and does not by itself establish a comparative safety effect. The registry record does not report a formal statistical comparison of these serious-event counts.

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

The primary result describes the observed difference in mean month-12 CADI score among participants with a biopsy-confirmed assessment. The low-dose group mean was 2.13 and the standard-dose group mean was 1.82. The unadjusted estimate is 0.31 points in the low-dose-minus-standard-dose direction, and its confidence interval includes values on both sides of zero. The sponsor's adjusted ANCOVA estimate is also positive, but its confidence interval includes zero. Together, these results indicate uncertainty about the size and direction of the difference, rather than a precise estimate.

The results do not establish that the regimens are equivalent. An absence of a statistically clear difference is not the same as evidence that any difference is negligible. The registry record does not report a prespecified equivalence or non-inferiority margin, nor a clinically important difference for CADI. The results also do not establish that one regimen is superior, since the reported primary intervals include zero.

The primary endpoint is a composite of biopsy-based histological categories. It is not a direct summary of every aspect of transplant function or of the participant's experience. The registry lists other outcomes, but their results are not all reported in the information available. Accordingly, the CADI estimate should not be generalized to unreported outcomes.

The analyzed primary population was smaller than the registered enrollment and consisted of participants with a qualifying biopsy assessment. The reason for the difference in counts and the handling of missing assessments are not reported in the registry record. This means the estimate should be understood as describing the analyzed subset, rather than automatically applying to all randomized participants. These statistical findings are not a basis for individual medical decisions.

18. Why This Trial Matters Statistically

This trial illustrates why a posted point estimate should be read together with its uncertainty and analysis population. The mean CADI scores differ numerically, but the primary confidence intervals include zero. That distinction prevents the observed contrast from being mistaken for a precise or definitive estimate. It also prevents a non-significant result from being mislabeled as proof of no difference.

The record also illustrates that one trial can contain more than one valid statistical estimate addressing a related question. The unadjusted recalculation is based on group summaries; the sponsor's reported ANCOVA is adjusted. Because the covariates are not reported, readers cannot fully assess the model or reproduce its estimate. Keeping method and population attached to each result is essential when the values differ.

Different outcomes use different analysis populations. The primary score is available for participants with a confirmed month-12 biopsy, while the safety denominators are larger. This difference highlights the importance of asking who contributed data to each result and how unavailable outcomes were handled. The registry record does not report enough missing-data detail to resolve that question for CADI.

Finally, planning illustrations based on an observed effect can show how demanding a future study might be under explicit assumptions, but they are not the original design justification and are not evidence of what the completed trial's power was. This distinction helps separate planning calculations from observed results and avoids treating a completed study's outcome as a retrospective power calculation.

19. 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 main endpoint analysis includes only participants with a biopsy-confirmed CADI assessment at month 12, with posted group sizes of 57 and 52. Although the population is labeled ITT, the stated biopsy requirement narrows the analyzed set. The registry record does not explain why other participants were not included, whether missingness differed by group, or how missing CADI scores were handled. This limits assessment of the representativeness of the primary result.

The adjusted ANCOVA result is reported without the covariates or full model specification. The estimate cannot therefore be independently reconstructed from the registry information. The unadjusted recalculation uses only group summaries and should not be treated as a substitute for a prespecified adjusted analysis. The record does not report the analysis plan needed to determine whether the model was specified before outcome data were examined.

The registry record does not report a clinically important CADI difference or a formal equivalence or non-inferiority margin. As a result, the statistical uncertainty cannot be translated into a threshold-based conclusion about whether a difference is small enough to be considered unimportant. The original sample-size justification and design assumptions are also not reported.

Although seven secondary outcomes are listed, numeric results in the record cover only selected outcomes. Multiplicity handling for secondary tests is not reported, and interim analyses and stopping rules are not reported. Safety results are presented as counts and selected event terms, without sufficient detail to assess overlap, attribution, or formal between-group comparisons. These limitations constrain the conclusions that can be drawn from the registry record alone.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study of CellCept (Mycophenolate Mofetil) Combined With Tacrolimus and Corticosteroids in Kidney Transplant Patients. — NCT00758602.
• Registry record last updated 2014-08-04; status last verified 2014-07.
• Results first posted 2014-08-04.
• 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.

23. Record Summary

NCT00758602 was a completed, randomized, open-label, parallel-group Phase 4 study sponsored by Hoffmann-La Roche. It enrolled 210 kidney-transplant patients to compare MMF and corticosteroids combined with low-dose or standard-dose tacrolimus. The recorded study start was 2008-09, and primary completion was 2011-02.

The primary endpoint was mean CADI score at month 12 after transplantation, analyzed among participants with a biopsy-confirmed assessment. The posted unadjusted mean difference was 0.31 points for low dose minus standard dose, with an interval spanning zero. The registry's adjusted ANCOVA estimate was 0.658, also with a 95% confidence interval spanning zero. The primary result is therefore uncertain in direction and magnitude. The registry lists seven secondary outcomes, but results are reported for only selected measures in the available record. Missing-data methods, multiplicity handling, and the original design assumptions are not reported in the registry record.