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 Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation (NCT00377962), a randomized phase 4 study. The primary outcome is Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00377962 |
| Phase | Phase 4 |
| Condition | Disorder Related to Cardiac Transplantation |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 282 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned maintenance heart or lung transplant patients with renal impairment. The primary endpoint population was defined as the intent-to-treat population: randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline assessment.
Intervention
The intervention combined everolimus with calcineurin inhibitor (CNI) reduction. The record describes everolimus dosing twice daily, adjusted to a target blood concentration of 3-8 ng/mL, and describes the CNI dose as reduced 50-70%. It also permits mycophenolic acid or azathioprine and steroids.
Comparator
The control regimen used CNI, with mycophenolic acid or azathioprine and steroids permitted. The record says immunosuppressants, including mycophenolic acid and azathioprine, continued unchanged according to local practice in the standard CNI arm; steroid treatment followed local practice.
Primary question
The primary endpoint was change in measured glomerular filtration rate (mGFR) from baseline to Month 12. The clinical question was whether starting everolimus alongside CNI reduction was associated with a different change in measured renal function than the control regimen. The registry record does not report the numerical primary-outcome results.
This is a comparison of treatment strategies, not a comparison of everolimus alone with no immunosuppression. Other immunosuppressive medicines could be used in both arms, and the control regimen reflected local practice. These details matter when interpreting the contrast: the trial addresses the assigned regimen as a whole, rather than isolating the contribution of one medicine.
The stated rationale was to investigate whether initiating everolimus together with CNI reduction in maintenance heart or lung transplant patients with renal impairment would improve renal function. That rationale identifies the intended question; it is not itself evidence that renal function improved. In the posted record, the primary endpoint definition is present, but its group results and the between-group estimate are not reported.
3. Trial Design
The registry describes a Phase 4, randomized, parallel-group trial with no masking. It lists an enrollment of 282 and a completed status. The listed study start was 2005-12, and primary completion was 2010-02. The sponsor was Novartis Pharmaceuticals. The title identifies heart and lung transplantation, and the listed condition is disorder related to cardiac transplantation.
Participants were assigned to everolimus with CNI reduction or a control regimen based on CNI. The intervention description allows mycophenolic acid or azathioprine and steroids; the control description says those immunosuppressants continued unchanged according to local practice, with steroid treatment also according to local practice. The intervention description specifies everolimus 0.75-1.5 mg twice daily, adjusted to a target concentration of 3-8 ng/mL, and CNI reduction of 50-70%. The remainder of the CNI target description is incomplete in the registry record, so no further target detail can be stated.
Because masking was listed as none, the trial was open-label: treatment assignment was not masked. Random assignment supports a comparison between allocated strategies, but it does not by itself establish that every later analysis retains the balance achieved at assignment. The primary endpoint's stated analysis population was restricted to randomized patients who received at least 1 dose and had at least 1 post-baseline assessment.
The record lists secondary outcomes covering mGFR and serum creatinine at Month 24, biopsy-proven acute rejection, death and graft loss, dialysis, and lung- or heart-specific measures. These include lung-subgroup changes in forced expiratory volume in 1 second and forced vital capacity, and heart-subgroup left ventricular parameters. Although the registry lists 12 outcome measures, it does not report analysis results for them in the material summarized in the record. A more detailed protocol, allocation ratio, recruitment setting, and statistical analysis plan 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.
Core Study: 0-12 Months
| Stage | Everolimus + CNI Reduction | Control |
|---|---|---|
| STARTED | 140 | 142 |
| COMPLETED | 112 | 133 |
| NOT COMPLETED | 28 | 9 |
Reasons for not completing this period:
| Reason | Everolimus + CNI Reduction | Control |
|---|---|---|
| Adverse Event | 18 | 2 |
| Death | 3 | 0 |
| Withdrew Consent | 5 | 2 |
| Administrative Reason | 1 | 1 |
| Unspecified reasons | 1 | 4 |
Extension Study: 12-24 Months
| Stage | Everolimus + CNI Reduction | Control |
|---|---|---|
| STARTED | 108 | 127 |
| COMPLETED | 98 | 123 |
| NOT COMPLETED | 10 | 4 |
Reasons for not completing this period:
| Reason | Everolimus + CNI Reduction | Control |
|---|---|---|
| Death | 1 | 1 |
| Adverse Event | 8 | 0 |
| Abnormal laboratory value | 1 | 0 |
| Unspecified reason | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population: All randomized patients who were given at least 1 dose of study drug and had at least 1 post-baseline assessment.
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.
| Characteristic | Unit | Everolimus + CNI Reduction | Control | Total |
|---|---|---|---|---|
| Participants analysed | 140 | 142 | 282 | |
| Age, Continuous | years | 59.2 (SD 9.5) | 56.4 (SD 10.7) | 57.8 (SD 9.96) |
| Sex: Female, Male: Female | Participants | 37 | 40 | 77 |
| Sex: Female, Male: Male | Participants | 103 | 102 | 205 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Measured Glomerular Filtration Rate (mGFR) From Baseline to Month 12, measured over Baseline to Month 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mL/min |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change in measured glomerular filtration rate (mGFR) from baseline to Month 12, measured in mL/min. The registry describes mGFR assessment using creatinine ethylenediamine tetraacetic acid (Cr-EDTA) clearance or an equivalent method. It defines a positive change score as indicating improved renal function.
mGFR is a measure of filtration function. Measuring change from baseline focuses the comparison on how the measurement moved during the specified follow-up interval, rather than on the Month 12 value alone. Baseline-to-follow-up change can help account for the fact that participants may begin with different renal function. A between-arm comparison of those changes would address whether the assigned strategies were associated with different trajectories over that interval.
The endpoint is continuous, and the registry identifies the intended summary as a mean with standard deviation. A mean describes the average change in the analyzed group; a standard deviation describes the spread of individual changes around that average. Neither quantity alone gives the uncertainty in a treatment contrast. That would ordinarily require an estimated between-group difference and an uncertainty measure, such as a confidence interval.
The numerical endpoint results, group means, standard deviations, between-group estimate, confidence interval, and p-value are not reported in the registry record. The endpoint definition therefore clarifies what the trial intended to measure, but the record does not allow the size or precision of the primary comparison to be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record states the primary endpoint and its direction: a positive mGFR change indicates improved renal function. However, it does not report the primary outcome values or a comparative estimate. It is therefore not possible to describe the observed average change in either arm, the difference between arms, or the precision of that difference. No conclusion about the direction or magnitude of the primary comparison can be drawn from the record.
The same caution applies to the listed secondary outcomes. The registry names Month 24 changes in mGFR and serum creatinine, rejection, death, graft loss, dialysis, and transplant-subgroup measures, but numerical results for these outcomes are not reported in the registry record. Outcome names describe what was planned or tracked; they do not establish what occurred.
For a continuous endpoint such as mGFR change, a useful treatment comparison would ordinarily present an estimate of the difference between group means, together with a confidence interval. The estimate would describe the observed contrast in average change. The interval would show the range of values compatible with the data under the analysis assumptions and indicate how precisely that contrast was estimated. A p-value, if reported, would address compatibility with a specified null hypothesis; it would not convey the size or clinical importance of the contrast. None of these primary comparison statistics is reported.
The record's definition of an intent-to-treat population is also relevant. It includes randomized patients who took at least 1 dose and had at least 1 post-baseline assessment. That definition is narrower than an analysis of every randomized patient, because it excludes those who did not meet the stated criteria. The number analyzed and the handling of participants without qualifying follow-up are not reported in the registry record.
The completed status and enrollment entry are features of trial conduct, not evidence about efficacy or safety. Likewise, randomization identifies the intended comparative design, but without posted outcome estimates it cannot answer whether the assigned strategies differed on mGFR. The appropriate statistical reading is therefore descriptive of what the record specifies, and explicit about what it leaves unreported.
Safety information is presented as counts of participants affected by serious and other adverse events in heart and lung groups at 12 and 24 months. These figures can describe reported event experience within the listed groups, but they do not substitute for the missing primary endpoint analysis. Their interpretation also depends on the listed at-risk counts, follow-up period, event definitions, and whether participants could contribute more than one event. The registry does not provide enough detail to infer a comparative causal effect from the counts alone.
9. Statistical Methods Explained
The registry identifies the primary endpoint as a continuous measure summarized by a mean and standard deviation. These summaries answer different questions. The mean describes the average change in mGFR among the analyzed participants. The standard deviation describes how dispersed individual change values are around that average. A large or small standard deviation does not, by itself, show whether the treatment contrast is estimated precisely; precision also depends on the amount of information in the analysis and the method used to estimate the contrast.
What would a confidence interval add?
A confidence interval around a between-group estimate communicates uncertainty in the estimated contrast. In general, a narrower interval indicates greater precision, while a wider interval indicates less precision. Its interpretation depends on the statistical model and assumptions used. A confidence interval is not a range containing a fixed proportion of individual participants' outcomes, and it is not proof that every value inside it is equally plausible. The registry record does not report a primary confidence interval or describe the method used to calculate one.
What does a p-value tell the reader?
In general, a p-value measures how incompatible the observed data are with a specified null hypothesis, under the assumptions of the test. It does not measure the probability that the null hypothesis is true, nor does it convey the size or practical importance of an effect. A small p-value can accompany a modest estimate, and a larger p-value can reflect imprecision. The primary p-value and the testing procedure are not reported in the registry record, so no significance claim can be assessed.
Why does the analysis population matter?
The stated primary population includes randomized participants who received at least 1 dose and had at least 1 post-baseline assessment. This definition is important because an analysis restricted by treatment receipt and follow-up availability can differ from an analysis retaining all randomized participants in their assigned groups. Missing follow-up may be related to health status, treatment tolerance, or other factors; when that happens, observed participants may not represent all randomized participants. These are general concerns, not claims about what occurred in this trial. The number included in the primary analysis and the reasons for any exclusions are not reported in the registry record.
Why can over-dispersion matter?
For count outcomes, over-dispersion means that variation in the counts exceeds what a simple model assumes. If a model ignores over-dispersion, standard errors can be too small and confidence intervals too narrow, making statistical evidence appear stronger than it is. This is a general consideration for count data, not a description of the analysis used in this trial. The registry record does not report a model for the event outcomes or whether over-dispersion was assessed.
How should subgroup outcomes be understood?
The record lists distinct heart- and lung-transplant subgroup outcomes, including lung function measures for the lung transplant subgroup and left ventricular parameters for the heart transplant subgroup. A subgroup estimate describes the population included in that subgroup analysis. It should not automatically be treated as proof that the treatment effect differs between subgroups; that requires a suitable comparison of effects, often through an interaction analysis. Such an analysis and its results are not reported in the registry record.
There are 12 listed outcome measures, but the record does not report the analysis results or statistical plan for them. When many outcomes are examined, the chance of at least one apparently notable finding can increase. General methods for addressing multiplicity include prespecifying a hierarchy, adjusting inference, or distinguishing primary from exploratory outcomes. Which, if any, approach was used is not reported. With no posted primary estimate, interval, p-value, or analysis details, the statistical evidence for the main comparison cannot be reconstructed from the registry entry.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 12 outcome measures, including the primary mGFR change endpoint and secondary renal, transplant, and safety outcomes. It does not report a multiplicity strategy. In general, testing several outcomes can increase the chance of a nominally unusual result even when no underlying effect exists. Prespecified outcome hierarchies, adjusted testing procedures, or clear separation of confirmatory and exploratory analyses are possible approaches. The registry record does not say whether any of these was used, and no statistical analysis plan is reported.
Missing-data handling is also not reported in the registry record. The stated primary analysis population required at least 1 dose and at least 1 post-baseline assessment, but the record does not describe how participants with no post-baseline assessment, incomplete follow-up, or missing mGFR measurements were handled. It does not report the amount or pattern of missing data, whether imputation was used, or whether sensitivity analyses assessed the effect of missingness. These omissions limit assessment of how representative the observed endpoint data may be.
The primary population definition is not an unrestricted analysis of all randomized participants: it applies the stated dose and follow-up criteria. The record does not report the number analyzed under that definition, the number excluded, or outcomes for excluded participants. The planned statistical model, covariate adjustment, and primary hypothesis-testing procedure are likewise not reported in the registry record.
These gaps matter because multiplicity and missing data affect how much confidence readers can place in an apparent result. They cannot be resolved from the completed status or the outcome descriptions. Since the registry record also does not report the numerical primary endpoint comparison, its statistical significance and robustness cannot be evaluated.
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 |
|---|---|---|---|
| Control: 12 Month Heart | 23 | 96 | 24.0% |
| Everolimus + CNI Reduction: 12 Month Heart | 40 | 94 | 42.6% |
| Control: 12 Month Lung | 17 | 46 | 37.0% |
| Everolimus+CNI Reduction: 12 Month Lung | 25 | 46 | 54.3% |
| Control: 24 Month Heart | 31 | 86 | 36.0% |
| Everolimus + CNI Reduction: 24 Month Heart | 25 | 69 | 36.2% |
| Control: 24 Month Lung | 21 | 41 | 51.2% |
| Everolimus + CNI Reduction: 24 Month Lung | 16 | 39 | 41.0% |
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 |
|---|---|
| Control: 12 Month Heart | 48 of 96 |
| Everolimus + CNI Reduction: 12 Month Heart | 75 of 94 |
| Control: 12 Month Lung | 33 of 46 |
| Everolimus+CNI Reduction: 12 Month Lung | 42 of 46 |
| Control: 24 Month Heart | 33 of 86 |
| Everolimus + CNI Reduction: 24 Month Heart | 29 of 69 |
Most frequent serious adverse event terms
| Event term | Organ system | Control: 12 Month Heart | Everolimus + CNI Reduction: 12 Month Heart | Control: 12 Month Lung | Everolimus+CNI Reduction: 12 Month Lung | Control: 24 Month Heart | Everolimus + CNI Reduction: 24 Month Heart |
|---|---|---|---|---|---|---|---|
| Pneumonia NOS | Infections and infestations | 3 of 96 | 7 of 94 | 3 of 46 | 6 of 46 | 2 of 86 | 0 of 69 |
| Pulmonary embolism | Vascular disorders | 1 of 96 | 1 of 94 | 2 of 46 | 2 of 46 | 1 of 86 | 2 of 69 |
| Urinary tract infection NOS | Infections and infestations | 1 of 96 | 3 of 94 | 1 of 46 | 0 of 46 | 1 of 86 | 2 of 69 |
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | 2 of 96 | 2 of 94 | 0 of 46 | 1 of 46 | 2 of 86 | 1 of 69 |
| Gastroenteritis NOS | Infections and infestations | 2 of 96 | 0 of 94 | 0 of 46 | 0 of 46 | 2 of 86 | 2 of 69 |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 96 | 1 of 94 | 1 of 46 | 1 of 46 | 0 of 86 | 0 of 69 |
| Oedema NOS | Cardiac disorders | 0 of 96 | 3 of 94 | 0 of 46 | 0 of 46 | 1 of 86 | 1 of 69 |
| Diarrhoea NOS | Gastrointestinal disorders | 0 of 96 | 2 of 94 | 1 of 46 | 0 of 46 | 1 of 86 | 1 of 69 |
| Upper respiratory tract infection NOS | Infections and infestations | 0 of 96 | 1 of 94 | 1 of 46 | 1 of 46 | 2 of 86 | 0 of 69 |
| Venous thrombosis deep limb | Vascular disorders | 1 of 96 | 2 of 94 | 0 of 46 | 0 of 46 | 1 of 86 | 1 of 69 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Control: 12 Month Heart | Everolimus + CNI Reduction: 12 Month Heart | Control: 12 Month Lung | Everolimus+CNI Reduction: 12 Month Lung | Control: 24 Month Heart | Everolimus + CNI Reduction: 24 Month Heart |
|---|---|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 15 of 96 | 18 of 94 | 12 of 46 | 11 of 46 | 12 of 86 | 7 of 69 |
| Oedema NOS | Cardiac disorders | 10 of 96 | 24 of 94 | 3 of 46 | 14 of 46 | 9 of 86 | 4 of 69 |
| Diarrhoea NOS | Gastrointestinal disorders | 4 of 96 | 15 of 94 | 3 of 46 | 7 of 46 | 0 of 86 | 4 of 69 |
| Headache NOS | Nervous system disorders | 7 of 96 | 7 of 94 | 3 of 46 | 5 of 46 | 1 of 86 | 0 of 69 |
| Upper respiratory tract infection NOS | Infections and infestations | 1 of 96 | 2 of 94 | 6 of 46 | 9 of 46 | 2 of 86 | 2 of 69 |
| Hypertension NOS | Vascular disorders | 5 of 96 | 4 of 94 | 4 of 46 | 6 of 46 | 0 of 86 | 3 of 69 |
| Leucopenia NOS | Blood and lymphatic system disorders | 0 of 96 | 8 of 94 | 0 of 46 | 8 of 46 | 1 of 86 | 1 of 69 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 5 of 96 | 6 of 94 | 2 of 46 | 3 of 46 | 0 of 86 | 1 of 69 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3 of 96 | 5 of 94 | 3 of 46 | 3 of 46 | 0 of 86 | 3 of 69 |
| Pneumonia NOS | Infections and infestations | 5 of 96 | 3 of 94 | 2 of 46 | 5 of 46 | 1 of 86 | 0 of 69 |
Serious events with the highest arm-level rate: pneumonia nos (17.1%), obliterative bronchiolitis (14.6%), squamous cell carcinoma (5.1%), basal cell carcinoma (4.9%), excessive bronchial secretion (4.9%).
The adverse-event record separates heart and lung transplant groups and reports serious adverse events and other adverse events at 12 and 24 months. For each group, it lists the number at risk and the number affected. These are counts for the specified group and time point; they should not be added across time points, since the record does not establish that those groups represent separate participants. The listed counts are descriptive and do not, by themselves, establish a treatment-related cause.
The registry lists serious adverse events for Control: 12 Month Heart as 23 among 96 at risk, and Everolimus + CNI Reduction: 12 Month Heart as 40 among 94 at risk. For the lung groups at 12 months, the listed serious-event counts are 17 among 46 at risk in control and 25 among 46 at risk with everolimus plus CNI reduction. At 24 months, the heart-group counts are 31 among 86 at risk in control and 25 among 69 at risk with everolimus plus CNI reduction; the lung-group counts are 21 among 41 at risk in control and 16 among 39 at risk with everolimus plus CNI reduction.
The record also lists other adverse-event counts for these groups, but the figures should be interpreted as group-level descriptive counts rather than as a direct measure of comparative risk. Death counts are not reported in the registry record. Listed serious-event terms include pneumonia NOS (17.1%), obliterative bronchiolitis (14.6%), squamous cell carcinoma (5.1%), basal cell carcinoma (4.9%), excessive bronchial secretion (4.9%), and bronchitis acute NOS (4.3%). The record does not provide enough detail to establish whether these terms were mutually exclusive or to infer treatment causality.
12. What the Result Does, and Does Not, Mean
This trial's stated objective was to investigate whether initiating everolimus alongside CNI reduction in maintenance heart or lung transplant patients with renal impairment would improve renal function. Its primary endpoint was a defined measurement of change in mGFR from baseline to Month 12. The registry also identifies the intended comparison groups and the primary analysis population.
Those design details clarify the question but do not answer it. The numerical primary results are not reported in the registry record. Without group estimates and a between-group comparison, the record does not show the observed direction or size of the mGFR contrast, or how precisely it was estimated. It therefore cannot support a claim that either regimen produced a greater average change, or that the regimens were similar.
Even when numerical results are available, a statistical difference and a clinically important difference are not interchangeable. The estimate's magnitude, uncertainty, relevance to patients, and context all matter. The registry record does not provide a threshold for a clinically important mGFR change, and it does not report the primary results needed to make that assessment.
The safety counts describe adverse events recorded in specified groups and follow-up periods. They do not establish that treatment caused an event, and they are not a complete substitute for a comparative safety analysis. The registry does not report deaths in these groups or a detailed safety analysis plan.
More generally, randomized allocation is a design feature that can support a fair comparison when the analysis follows an appropriate plan and missing outcomes are handled suitably. It does not remove the need to examine the actual results, analysis population, uncertainty, and limitations. Here, the registry record gives important design and endpoint information, but the central efficacy comparison and several details needed to evaluate its reliability are not reported. The meaning of the trial's posted record is therefore principally about what was intended to be studied, not what the primary endpoint showed.
13. Why This Trial Matters Statistically
This trial illustrates why endpoint definitions and result reporting need to be read together. The registry specifies a continuous renal-function outcome, its measurement approach, the follow-up interval, and the direction associated with improvement. Those details make the intended estimand more concrete: the focus is change in measured filtration from baseline to Month 12, compared between assigned treatment strategies.
At the same time, a well-defined endpoint is not a result. Without the group summaries, contrast, uncertainty interval, and analysis details, readers cannot quantify the observed effect or judge its precision. This distinction is important in clinical research: registration entries can preserve the planned question and some design information, while still lacking the results required for statistical interpretation.
The record also presents a setting in which treatment strategies involve more than a single drug. Everolimus is paired with CNI reduction, while background immunosuppression is partly governed by local practice. The comparison therefore concerns regimen strategies in heart and lung transplant populations, with additional organ-specific outcomes. Clear reporting of subgroup estimates and a formal assessment of whether effects differ between subgroups would be needed to support claims about different responses by transplant type; those results are not reported.
Finally, the record underscores the value of documenting multiplicity, missing-data methods, and the analysis population. These choices can affect the credibility and interpretation of estimates, particularly when several outcomes and subgroups are listed. The registry record's omissions do not establish that the trial analyses were inadequate, but they prevent readers from assessing those aspects from the registry entry.
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 principal limitation for interpreting efficacy is that numerical results for the primary mGFR endpoint are not reported in the registry record. Group means, standard deviations, the between-group estimate, its uncertainty, and the primary test result are absent. The record also does not report numerical results for the listed secondary outcomes. Consequently, neither the primary comparison nor the consistency of findings across outcomes can be assessed.
The analysis population is described as randomized participants who received at least 1 dose and had at least 1 post-baseline assessment. The record does not report the number analyzed, exclusions, missing outcome counts, or how missing measurements were handled. It does not describe whether the analysis followed assigned treatment regardless of subsequent treatment changes, or whether sensitivity analyses were conducted.
The registry identifies the trial as randomized, parallel, and unmasked, but does not report the allocation ratio, randomization procedure, concealment approach, or statistical analysis plan. The intervention description is incomplete at the end of its CNI target information, so the full target specification cannot be evaluated from the record. Background immunosuppression and steroids in the control arm followed local practice, which is relevant context for understanding the treatment contrast.
Subgroup outcomes are listed for heart and lung transplant participants, but the registry does not report subgroup results or analyses testing whether effects differed by transplant type. It also does not report a multiplicity approach despite listing multiple outcomes. These are limitations of the information available in the registry record; they do not establish what analyses were or were not conducted outside the record.
For safety, counts are reported by organ group and follow-up period, but the record does not provide a detailed explanation of event collection, attribution, or handling of repeated events. Death counts are not reported in the registry record. These constraints limit the scope of conclusions that can be drawn from the posted safety summaries.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation — NCT00377962.
- Registry record last updated 2020-07-30; status last verified 2020-07.
- Results first posted 2011-04-18.
- 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
The record describes a completed, Phase 4, randomized, open-label, parallel-group trial sponsored by Novartis Pharmaceuticals. It lists enrollment of 282, a study start of 2005-12, and primary completion of 2010-02. The trial compared everolimus with CNI reduction against a control CNI regimen in maintenance heart or lung transplant patients with renal impairment.
The primary endpoint was change in mGFR from baseline to Month 12, measured in mL/min. The stated primary population included randomized participants who received at least 1 dose and had at least 1 post-baseline assessment. The record lists 12 outcome measures and provides adverse-event counts by transplant group and follow-up period.
Numerical primary and secondary outcome results, the statistical analysis plan, multiplicity methods, missing-data methods, and details of the primary comparison are not reported in the registry record. The entry therefore documents the trial question and selected design features but does not allow the primary treatment contrast to be quantified.