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 Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3 (NCT00878969), a randomized phase 3 study. The primary outcome is Interleukin-6 (IL-6).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00878969 |
| Phase | Phase 3 |
| Condition | Oxidative Stress, Endothelial Dysfunction |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 78 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vanderbilt University |
| Results posted | Yes |
2. Clinical Question
Population
People enrolled in a study concerning oxidative stress and endothelial dysfunction in the dialysis setting. The registry reports an enrollment of 78, but does not provide fuller eligibility criteria or a detailed description of the enrolled population.
Intervention
Daily oral valsartan, an angiotensin receptor blocker (ARB): 80 mg for 1 week, followed by 160 mg for 18 months.
Comparator
Daily oral ramipril, an angiotensin-converting enzyme (ACE) inhibitor: 2.5 mg for 1 week, followed by 5 mg for 18 months; or matching placebo on the same stated schedule.
Primary question
The stated primary endpoint was serum interleukin-6 (IL-6), assessed at baseline and 18 months. The study purpose also describes examining long-term effects of the medication classes on chemicals in the body and carotid arteries, but the registry does not report a carotid-artery measure as an analyzed outcome.
The central clinical research question was whether the study medications differed in their long-term effects on the selected biological measures. The primary endpoint description identifies IL-6 as a sensitive laboratory assay for a pro-inflammatory cytokine used to evaluate the inflammatory response. The planned comparison therefore concerned a laboratory marker, not a reported clinical event or symptom outcome.
The available record does not answer that question with an effect estimate. It states that only 37 subjects completed the study, described as 18% of the goal, and that no formal analyses were performed. It further states that IL-6 data were not collected for any enrolled participants. Thus, the research question is identifiable, but the posted results do not establish how IL-6 changed over time or whether changes differed among the groups.
3. Trial Design
The registry describes a phase 3, randomized, quadruple-masked, parallel-group study. Its listed interventions were valsartan, ramipril and matching placebo. A parallel-group design assigns participants to distinct treatment groups and follows each group over the study period; it does not imply that each participant received every intervention. Random allocation is intended, in general, to reduce systematic differences between groups at enrollment. The record does not provide details of the randomization sequence or allocation concealment.
The listed medication schedules began with a lower daily oral dose for 1 week and then continued at the stated dose for 18 months. The placebo schedule is described as matching placebo, likewise taken daily for 1 week and then for 18 months. The record identifies the trial as quadruple-masked, but does not specify which roles were masked or how masking was maintained.
The enrollment was 78. The record gives a primary completion date of 2015-06 and a start date of 2010-01, and lists the study status as terminated. It does not state why the study was terminated, so no reason can be inferred from the status alone. The primary outcome timeframe was baseline and 18 months.
The study description states that 210 subjects were needed to complete the study to be able to detect an effect, based on the investigators’ power calculations. The registry reports 37 completed subjects, described as 18% of the goal. These planning and completion figures are distinct: the stated target is not the number observed to complete, and the completion count does not show that the intended endpoint was measured. The record confirms that IL-6 data were not collected and that no formal analyses were performed.
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.
Before assignment: There is a 3-week period between enrollment and assignment to treatment group. This "washout" period is to ensure that no blood pressure medicines (ARBs or ACE inhibitors) are left in the body. Although 123 subjects were enrolled, only 78 were assigned to a treatment group (45 subjects were screen failures).
Overall Study
| Stage | Valsartan | Ramipril | Placebo |
|---|---|---|---|
| STARTED | 25 | 27 | 26 |
| COMPLETED | 10 | 12 | 15 |
| NOT COMPLETED | 15 | 15 | 11 |
Reasons for not completing this period:
| Reason | Valsartan | Ramipril | Placebo |
|---|---|---|---|
| Physician Decision | 5 | 3 | 2 |
| Withdrawal by Subject | 1 | 6 | 3 |
| kidney transplant | 2 | 3 | 2 |
| Adverse Event | 3 | 1 | 2 |
| Lost to Follow-up | 2 | 1 | 0 |
| Protocol Violation | 2 | 0 | 0 |
| Death | 0 | 0 | 2 |
| Pregnancy | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Based on our power calculations, we needed 210 subjects to complete the study to be able to detect an effect. Given that only 37 subjects completed the study (18% of goal), no formal analyses were performed. Specifically, data were not collected for this assessment for any of the participants enrolled in the study.
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 | Valsartan | Ramipril | Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 25 | 27 | 26 | 78 | |
| Age, Continuous | years | 53 (SD 13) | 53 (SD 13) | 49 (SD 9) | 52 (SD 12) |
| Sex: Female, Male: Female | Participants | 11 | 8 | 9 | 28 |
| Sex: Female, Male: Male | Participants | 14 | 19 | 17 | 50 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 | 6 | 1 | 10 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 22 | 21 | 25 | 68 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 13 | 16 | 15 | 44 |
| Race (NIH/OMB): White | Participants | 10 | 7 | 9 | 26 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 2 | 4 | 2 | 8 |
| Region of Enrollment: United States | participants | 25 | 27 | 26 | 78 |
6. Primary Endpoint
The registry lists the primary outcome as Interleukin-6 (IL-6), measured over baseline and 18 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was interleukin-6 (IL-6), with measurement intended at baseline and 18 months. The registry describes IL-6 as a sensitive laboratory assay for serum levels of interleukin-6, a pro-inflammatory cytokine used to evaluate the inflammatory response. The unit, statistical parameter and dispersion measure are not reported in the registry record.
As a general statistical and biological concept, a laboratory marker can be used to characterize a biological response without itself being a direct measure of how a participant feels, functions or experiences a clinical event. Repeated assessment at baseline and a later timepoint can, in principle, describe change over time and permit comparison of that change across randomized groups. Interpreting such comparisons requires measured values and an analysis that accounts for the trial design and the data available.
For this trial, the endpoint’s stated purpose cannot be assessed from the posted outcome results: the record says IL-6 data were not collected for any enrolled participants and that no formal analyses were performed. There is consequently no reported group value, change estimate, uncertainty interval or test of a between-group difference. The endpoint definition explains what the investigators intended to measure, but it does not supply evidence about the direction or size of any effect.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The key statistical fact is that the designated primary endpoint has no analyzed result in the registry record. IL-6 was specified for assessment at baseline and 18 months, but the record states that data for this assessment were not collected for any enrolled participants. It also states that no formal analyses were performed. Therefore, the posted results cannot quantify an IL-6 value, a change from baseline, or a difference among valsartan, ramipril and placebo.
The record reports 78 enrolled subjects and 37 who completed the study, described as 18% of the goal. It also states that 210 subjects were needed to complete the study to be able to detect an effect, based on power calculations. These registry entries describe enrollment, completion and the stated target; they do not constitute an observed treatment effect. In particular, the completion figure cannot substitute for endpoint observations, because the record explicitly says that the IL-6 assessment data were not collected.
There is no reported estimate of the effect’s size or direction, and no confidence interval or p-value for the primary endpoint. A confidence interval, in general, describes a range of values compatible with the data and analysis under its assumptions. A p-value, in general, measures how unusual the observed data would be under a specified null model. Neither can be interpreted for this endpoint when no formal analysis or endpoint data are reported. The lack of an estimate is not evidence that the groups were equal, nor does it show that they differed.
The registry lists adverse-event counts separately. Those counts describe participants reported as affected in each group, not the primary IL-6 comparison. The posted record does not provide a formal comparative analysis of those safety counts. The listed serious-event terms and percentages also cannot be treated as an overall treatment-effect analysis, since their denominators and relationship to the group-level counts are not described in the record.
Interpretation should therefore remain descriptive and limited to the record: a randomized trial with three listed groups, a stated biological endpoint, fewer completed subjects than the stated completion target, and no formal endpoint analysis because IL-6 data were not collected. The study’s purpose and design do not fill the gap left by absent outcome measurements. The registry record does not report a reason for termination or further details that would explain why the primary assessment was not collected.
9. Statistical Methods Explained
The design and result status determine what statistical conclusions are possible. The trial is described as randomized and parallel-group, with valsartan, ramipril and placebo as the listed interventions. Randomization is a general method for assigning participants to groups by chance. Its purpose is to limit systematic allocation differences, so that a between-group comparison can have a causal interpretation when the outcome is measured and the analysis appropriately follows the design. Randomization alone does not ensure that every planned measurement is obtained, nor does it produce an effect estimate without outcome data.
What can a parallel-group comparison estimate?
In general, a parallel-group trial can compare outcomes between participants allocated to different interventions. For the stated primary endpoint, a suitable analysis would need IL-6 measurements and a defined approach to comparing the relevant groups at the specified assessment times. Depending on the prespecified analysis, the comparison might concern endpoint values, changes over time, or another parameter. The registry record does not report a statistical parameter or analysis method for IL-6, and it states that no formal analyses were performed. It would therefore be inappropriate to attribute any particular model or comparison to this trial.
The record says IL-6 was intended to be assessed at baseline and 18 months. In general, baseline information can help describe the starting distribution and may be incorporated into an analysis, while follow-up measurements provide information about outcomes after treatment begins. The exact role of baseline values depends on the planned model. That model is not reported in the registry record, and in this case the endpoint values themselves were not collected.
How should uncertainty be understood?
A point estimate is a numerical summary of an effect or group value. A confidence interval expresses statistical uncertainty around an estimate under the assumptions of the analysis. A narrow interval generally indicates greater precision than a wide interval, while the interval’s location indicates which effect values are compatible with the data and method. These are general interpretations; no point estimate or confidence interval for IL-6 is reported for this trial. Without measured outcome values, there is no basis for calculating or interpreting endpoint uncertainty.
A significance test evaluates data against a specified null hypothesis and model. Its result depends on the data, assumptions and chosen analysis. The registry states that no formal analyses were performed, so there is no reported primary-endpoint test statistic or p-value. An unreported p-value should not be inferred from the enrollment, completion count, design label or safety counts.
What does the stated power target mean?
The registry says that, based on power calculations, 210 subjects needed to complete the study to be able to detect an effect. As a general concept, statistical power is the probability that a specified analysis will reject a null hypothesis under an assumed effect and other assumptions. A planning target relies on choices about the effect to detect, outcome variability, significance level, allocation and analysis. The record does not report those calculation details, so they cannot be reconstructed or evaluated.
Power is a planning property, not a description of what the trial found. The 37 subjects reported as completing the study, or the stated 18% of the goal, do not establish an observed effect and cannot be used as observed power. Because the endpoint was not collected and no formal analysis was performed, the registry does not support a conclusion about whether the study would have detected a true difference.
Why do missing measurements matter?
Missing outcome information is a problem distinct from randomization. In general, missingness can reduce precision and can bias an estimate if the reasons measurements are absent are related to treatment assignment or outcome values. Statistical approaches to missing data rely on assumptions, and sensitivity analyses can examine how conclusions change under alternative assumptions. Here, the record does not describe a missing-data model, imputation, or sensitivity analysis. More fundamentally, it states that IL-6 data were not collected for any enrolled participants, rather than reporting a partial set of measurements to analyze.
The registry reports that 37 subjects completed the study, but it does not provide an endpoint analysis population or explain the relationship between completion and the intended IL-6 assessments beyond stating that those data were not collected. Completion status alone cannot be treated as evidence that the endpoint was observed. Nor does the record establish whether any other outcome can answer the designated primary question.
What can the safety counts establish?
The adverse-event information is descriptive. It lists participants at risk and participants affected by serious and other adverse events for each arm, as well as several serious-event terms with percentages. In general, a comparative safety analysis would require clear definitions, observation periods, denominators and an analysis that accounts for the study design. The registry record does not report those details or a formal between-group safety analysis. The counts can be stated as posted, but they should not be converted into an unreported estimate of comparative risk.
Overall, the methods support a clear account of intended design and reporting gaps, rather than a treatment-effect calculation. No method can recover the uncollected IL-6 values from the design description or the completion count. The record does not report the statistical analysis plan, the endpoint model, multiplicity procedures, or an explanation for termination.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, IL-6, and reports no formal analyses. It does not report a statistical analysis plan, a hierarchy of hypotheses, or procedures for controlling multiplicity. Multiplicity arises in general when several outcomes, timepoints, groups or statistical tests are examined, increasing the chance of at least one apparently notable result under repeated testing. Whether a correction or other strategy was planned cannot be determined from this record.
The stated primary endpoint timeframe was baseline and 18 months. The intervention list contains three groups, so a complete analysis plan would need to specify which group comparisons addressed the research question and how the repeated timepoints were handled. The registry does not report those choices. It would be speculative to describe a particular set of pairwise comparisons or a correction method.
The record states that IL-6 data were not collected for any enrolled participants and that no formal analyses were performed. This is not merely a case of a reported estimate with some missing observations: there is no posted primary-endpoint dataset or analysis to interpret. The record does not report imputation, a missing-data assumption, a sensitivity analysis, or an analysis population definition. It also does not explain why the assessment data were not collected.
Although 37 subjects are reported as completing the study, the registry does not describe an intention-to-treat, per-protocol or other analysis population for the primary endpoint. Completion should not be equated with an analyzed population, particularly given the explicit statement that no IL-6 data were collected. The reason for termination and any associated changes to data collection or analysis are not reported in the registry record.
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 |
|---|---|---|---|
| Valsartan | 8 | 25 | 32.0% |
| Ramipril | 9 | 27 | 33.3% |
| Placebo | 9 | 26 | 34.6% |
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 |
|---|---|
| Valsartan | 19 of 25 |
| Ramipril | 15 of 27 |
| Placebo | 15 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | Valsartan | Ramipril | Placebo |
|---|---|---|---|---|
| infection | Infections and infestations | 1 of 25 | 3 of 27 | 2 of 26 |
| pulmonary | Respiratory, thoracic and mediastinal disorders | 2 of 25 | 3 of 27 | 1 of 26 |
| cardiac | Cardiac disorders | 3 of 25 | 1 of 27 | 1 of 26 |
| hypertension/hypotension | Vascular disorders | 1 of 25 | 1 of 27 | 2 of 26 |
| electroyte disorder | Metabolism and nutrition disorders | 1 of 25 | 1 of 27 | 1 of 26 |
| musculoskeletal | Musculoskeletal and connective tissue disorders | 0 of 25 | 2 of 27 | 0 of 26 |
| GI upset | Gastrointestinal disorders | 0 of 25 | 1 of 27 | 1 of 26 |
| generalized symptoms | General disorders | 2 of 25 | 0 of 27 | 0 of 26 |
| Death | General disorders | 0 of 25 | 0 of 27 | 2 of 26 |
| access related | Vascular disorders | 1 of 25 | 0 of 27 | 0 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Valsartan | Ramipril | Placebo |
|---|---|---|---|---|
| access related | Vascular disorders | 8 of 25 | 5 of 27 | 5 of 26 |
| GI upset | Gastrointestinal disorders | 2 of 25 | 5 of 27 | 8 of 26 |
| cardiac | Cardiac disorders | 4 of 25 | 5 of 27 | 5 of 26 |
| hypertension/hypotension | Vascular disorders | 6 of 25 | 7 of 27 | 0 of 26 |
| pulmonary | Respiratory, thoracic and mediastinal disorders | 2 of 25 | 5 of 27 | 3 of 26 |
| pain | General disorders | 3 of 25 | 2 of 27 | 4 of 26 |
| electrolyte disorder | Metabolism and nutrition disorders | 2 of 25 | 3 of 27 | 2 of 26 |
| musculoskeletal | Musculoskeletal and connective tissue disorders | 3 of 25 | 0 of 27 | 4 of 26 |
| infection | Infections and infestations | 4 of 25 | 0 of 27 | 3 of 26 |
| generalized symptoms | General disorders | 2 of 25 | 5 of 27 | 0 of 26 |
Serious events with the highest arm-level rate: cardiac (12.0%), infection (11.1%), pulmonary (11.1%), generalized symptoms (8.0%), hypertension/hypotension (7.7%).
The registry reports serious and other adverse-event counts by arm. For serious adverse events, the listed at-risk and affected counts are 25 and 8 for valsartan, 27 and 9 for ramipril, and 26 and 9 for placebo. For other adverse events, the corresponding counts are 25 and 19 for valsartan, 27 and 15 for ramipril, and 26 and 15 for placebo. These are descriptive counts, not a reported comparative analysis.
The registry also lists cardiac (12.0%), infection (11.1%), pulmonary (11.1%), generalized symptoms (8.0%), hypertension/hypotension (7.7%) and Death (7.7%) among the top serious-event terms. The record does not specify the denominators or the method used to generate those percentages, so they should be read as posted rather than reinterpreted as group-specific risks. The separate death counts are not reported in the registry record.
The adverse-event time period, event definitions, severity grading and statistical comparisons are not described in the posted information. The figures therefore provide limited descriptive safety reporting; they do not establish a causal difference among the interventions.
12. What the Result Does, and Does Not, Mean
The posted results establish what was intended and what was reported, but they do not establish an IL-6 treatment effect. The trial was randomized, with three listed arms, and IL-6 was designated for assessment at baseline and 18 months. The registry states that no IL-6 data were collected for any enrolled participants and that no formal analyses were performed. There is consequently no numerical estimate of the primary outcome to interpret.
This distinction matters because a stated endpoint is not the same as an observed result. The outcome description gives a rationale for measuring serum IL-6: it is described as a sensitive assay for a pro-inflammatory cytokine used to evaluate the inflammatory response. That description does not tell readers whether levels changed, whether groups differed, or how precisely any difference might have been estimated.
The 210-subject completion target and 37 reported completions describe the study’s stated power calculation target and completion status. They are not evidence of efficacy or lack of efficacy. The registry does not provide enough information to assess the assumptions behind the power calculation, and the absence of endpoint data means that no observed effect or observed power can be inferred.
The adverse-event figures are a separate part of the record. They show reported counts by arm and a list of serious-event terms with percentages, but do not provide a formal safety comparison or enough detail to interpret those percentages as arm-specific rates. They should not be substituted for the missing primary outcome analysis.
In short, the registry record documents a trial design and limited outcome reporting, not a completed statistical test of the primary research question. It does not demonstrate that the treatments had the same effect, nor that they had different effects. The reason for termination, the reasons the primary assessment was not collected, and additional analytic details are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between study design, planned sample size and analyzed results. Randomization and masking describe important features of how a trial was intended to operate, but they cannot compensate for the absence of a measured primary endpoint. Because the registry states that IL-6 data were not collected, the main biological comparison cannot be estimated from the posted results.
The stated need for 210 subjects to complete the study, alongside 37 reported completions and 18% of the goal, highlights why recruitment and follow-up targets matter for precision and the ability to detect a prespecified effect. In general, smaller-than-planned completion can reduce information and make estimates less precise. In this particular record, however, the central limitation is even more direct: there are no IL-6 observations to analyze. No inference about the size or direction of an effect follows from the completion figures.
The record also illustrates why registry outcome definitions and results should be read separately. A clear endpoint description can identify what a trial sought to measure, while still leaving the research question unanswered when results are not collected or analyzed. Likewise, adverse-event counts may offer descriptive information without constituting a comparative safety analysis.
For clinical researchers and biostatisticians, the case underscores the importance of transparent reporting about outcome collection, analysis populations, missing-data handling, multiplicity and reasons for study termination. Those details are not reported. Their absence limits the ability to assess the planned analysis and to distinguish protocol decisions from events during conduct. The appropriate statistical conclusion is bounded: the primary endpoint has no reported analysis, so the registry cannot support an estimate of the treatment differences it set out to study.
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 consequential limitation is that the primary endpoint was not measured: the registry states that IL-6 data were not collected for any enrolled participants. No formal analyses were performed. There is thus no primary-outcome estimate, measure of uncertainty or statistical test available for interpretation.
The registry reports 78 enrolled and 37 completed subjects, while stating that 210 subjects needed to complete the study to be able to detect an effect. The details of the power calculation, including its assumptions and the effect it was designed to detect, are not reported in the registry record. The record also does not explain the difference between enrollment and completion or provide reasons for the reported completion level.
The study status is terminated, but the reason for termination is not reported. The record does not explain why the IL-6 assessment was not collected, whether this was a protocol change, or whether other study measurements were available for analysis. The methods for randomization and masking, the prespecified statistical model, analysis populations, multiplicity handling and missing-data procedures are not reported.
For safety, counts and serious-event terms are listed, but the observation period, event definitions, denominators for the term percentages and formal comparative analyses are not described. These reporting gaps constrain interpretation of both the primary endpoint and the adverse-event information. They do not justify conclusions about unreported outcomes or the reason the study ended.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Genes, Fibrinolysis and Endothelial Dysfunction- Dialysis Aim 3 — NCT00878969.
- Registry record last updated 2016-02-15; status last verified 2016-01.
- Results first posted 2016-02-15.
- 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 registry record describes a phase 3 randomized, quadruple-masked, parallel-group study of valsartan, ramipril and matching placebo. Enrollment was 78. The listed regimens were taken orally each day, with a 1-week initial dose followed by the stated dose for 18 months. The primary outcome was serum IL-6 at baseline and 18 months.
The record reports 37 completed subjects, described as 18% of the goal, and states that 210 subjects were needed to complete the study based on power calculations. It also states that IL-6 data were not collected for any enrolled participants and that no formal analyses were performed. The study status is terminated; the reason is not reported in the registry record.
Serious and other adverse-event counts are listed by arm, along with top serious-event terms. No formal comparative safety analysis is reported. The posted information therefore describes the trial and some safety counts, but does not provide an analyzed primary-endpoint result.