A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP (NCT06362759), a randomized phase 2 study. The primary outcome is Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90.

2. Clinical Question

3. Trial Design

This Phase 2 study evaluated quarterly and monthly subcutaneous TOUR006 in participants with chronic kidney disease and elevated hs-CRP. The registry lists randomized allocation, a parallel-group model, quadruple masking, and placebo control. Enrollment was 143, and the record lists the study as completed.

The intervention schedules differed by dose. Participants assigned to 15 mg were scheduled to receive TOUR006 on Days 1, 30, 60, 90, 120, and 150. The 25 mg and 50 mg groups were scheduled to receive TOUR006 on Days 1 and 90, with placebo at Days 30, 60, 120, and 150. The placebo group was scheduled to receive placebo at all listed timepoints. These schedules are the registry descriptions; the record does not establish whether every participant received every scheduled dose.

The primary outcome was measured through Day 90. Its analysis population included randomized participants who received any amount of investigational product, met the baseline hs-CRP criterion, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days. This is not necessarily the same population as all enrolled participants or everyone included in safety reporting.

The record lists a start date of 2024-05-15 and a primary completion date of 2025-03-06. It does not report the rationale for the selected enrollment target, the randomization procedure, the allocation ratio, or further operational details of masking. Those details should not be inferred from the design labels alone.

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: Of the 454 initial and re-screenings (where applicable), 143 were randomized to receive treatment or placebo.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (modified-ITT)

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: Includes all randomized participants who received any amount of investigational product, had a baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment in the first 90 days of study. (Modified-ITT)

6. Primary Endpoint

The registry lists the primary outcome as Time-Averaged Percent Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP) Through Day 90, measured over Baseline through 90 days. Baseline is defined as the average of the last two available visits prior to study treatment administration..

The primary endpoint was the time-averaged percent change from baseline in hs-CRP through Day 90. Baseline was defined as the average of the last two available visits before study treatment. The registry defines the time-averaged value as the area under the curve for percent change from baseline divided by the number of days from the observed Day 30 to Day 90 visits. It specifies use of the linear trapezoidal rule and the observed visit days.

Unlike a result at one scheduled visit, this endpoint incorporates measurements across the stated interval. In general, averaging information over time can describe the course of a measured response during that interval rather than its value at a single visit. The registry’s calculation depends on the observations and their actual visit timing; the approximate 60-day interval in the description assumes visits occur according to protocol.

The endpoint is expressed as a percent change in an inflammatory marker, not as a clinical event or a direct measure of kidney function. The registry lists other objectives, including safety, tolerability, pharmacokinetics, and additional hs-CRP measures. The reason this particular hs-CRP summary was chosen as the primary endpoint is not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a continuous outcome summarized by medians and interquartile ranges in the registry’s outcome description. The displayed arm-level results include medians and confidence intervals; an interquartile range is not shown in the posted arm results. The registry reports quantile regression for the between-group analyses. In general, quantile regression estimates a specified quantile, such as a median, while allowing the relationship between group and outcome to be assessed without requiring the outcome to follow a normal distribution. This is a general explanation of the method, not a description of unreported model details.

What do the confidence intervals convey?

A confidence interval describes statistical uncertainty around an estimated contrast under the assumptions of the analysis. Narrower intervals indicate greater precision than wider intervals on the same scale. The primary comparisons’ reported intervals are for net differences between each active group and placebo, not the arm-level medians themselves. The registry reports 95% confidence intervals for all three comparisons. A confidence interval is not a guarantee that the true effect lies within its bounds, and it does not address bias from missing data, population selection, or other design limitations.

How should the p-values be read?

A p-value assesses how compatible the observed data are with a specified null hypothesis under the analysis assumptions. The registry reports p < 0.001 for each primary comparison. This does not state the probability that the null hypothesis is true, nor does it measure the size or clinical importance of an effect. The posted estimates and confidence intervals are needed to understand the direction, scale, and precision of the contrasts. The record does not report whether the primary comparisons were adjusted for testing multiple doses.

Why does the endpoint use measurements over time?

The endpoint is based on the area under the curve for percent change from baseline, divided by the number of days in the observed interval between Day 30 and Day 90. The registry specifies the linear trapezoidal rule using actual visit days. In general, the trapezoidal rule approximates the area under a curve by connecting adjacent observed values with straight lines. The resulting summary reflects measurements over an interval, but it is influenced by the available measurements and their timing. The registry does not report further sensitivity analyses for alternative visit patterns.

What does the secondary binary comparison estimate?

One posted secondary outcome counts participants with time-averaged hs-CRP <2 mg/L through 90 days. The registry reports Cochran-Mantel-Haenszel tests for comparisons of placebo with the 25 mg and 50 mg groups, each with p < 0.001. In general, this method assesses association between group and a categorical outcome while accounting for stratification factors. The stratification factors used for these analyses are not reported in the registry record. The record does not list a corresponding sponsor estimate and confidence interval for these comparisons.

The additional unadjusted binary re-calculations use the posted participant counts and are simple, unadjusted comparisons. They are not the sponsor’s analysis and should not replace it. Because the registry reports multiple arms and outcomes, a p-value from an unadjusted calculation does not account for the wider set of tests unless an adjustment is specified. The record does not report such an adjustment plan.

What do the sample-size illustrations mean?

The planning illustrations are computed from the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They show participants per arm for 80% power and participants per arm for 90% power under the stated fractions of the observed effect. For the 25 mg comparison, planning for 100% of the observed effect gives 12 participants per arm for 80% power and 16 for 90% power; planning for 75% gives 22 and 29; planning for 50% gives 49 and 65. For the 50 mg comparison, the corresponding values are 13 and 16 for 100%, 23 and 30 for 75%, and 50 and 67 for 50%.

These values are planning illustrations, not observed power and not evidence that the original study was designed around these assumptions. Because they use the observed effects, they do not independently validate the trial’s design or account for uncertainty in those effects. The trial’s own sample-size justification is not reported in the registry record.

10. Analyses Reported by the Sponsor

The registry’s own primary analyses use quantile regression and report net contrasts against placebo, with 95% confidence intervals and p-values. For the 25 mg and 50 mg comparisons, the sponsor reports median differences; for 15 mg, the reported parameter is a mean difference. That distinction should be preserved when describing the results rather than treating the three estimates as identical summaries.

The record’s posted arm summaries and sponsor comparisons form the basis for the interpretation of the primary outcome. No discrepancy is flagged between the sponsor’s reported analysis and the recalculation status in the record. The sponsor’s own analysis takes precedence where a discrepancy exists; none is identified for these results.

Recalculated values, when available, are simple unadjusted calculations from posted summary statistics. They cannot reproduce model-based analyses without the underlying participant-level data and the full model specification. The registry does not report all details needed to independently reconstruct the quantile-regression analyses, including any covariates or additional model settings. The sponsor’s estimates should therefore remain the principal inferential results, while recalculations serve only as supplementary checks rather than substitutes.

11. Multiplicity, Missing Data and Analysis Populations

The primary analysis population is defined in the registry: participants were randomized, received any amount of investigational product, had baseline hs-CRP ≥1.9 mg/L, and did not miss more than one post-baseline hs-CRP assessment during the first 90 days. The record labels this population modified intention-to-treat. This definition excludes some randomized participants by treatment receipt, baseline value, or assessment availability, so the primary result does not necessarily represent every randomized participant.

The registry does not report how missing hs-CRP values were handled in the endpoint calculation beyond the population eligibility rule. It also does not report whether additional imputation, model-based handling, or sensitivity analyses were used. The endpoint definition relies on observed visit days, making the timing and availability of measurements relevant to its construction. The potential effect of missing observations on the estimates cannot be assessed from the registry record alone.

Three active-dose comparisons are reported for the primary outcome, and multiple secondary outcomes are listed. The record does not report whether the primary comparisons were adjusted for multiplicity, whether a hierarchical testing sequence was used, or how secondary endpoints were treated statistically. The reported p-values should therefore be read as the results of the listed tests, not assumed to be adjusted across all comparisons and outcomes.

The trial is listed as completed, but interim analyses and any associated decision rules are not reported in the registry record. The sample-size justification and detailed statistical analysis plan are also not reported. These missing details limit assessment of prespecification, the inferential status of secondary analyses, and the robustness of conclusions to missing data and multiple testing.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: acute kidney injury (5.7%), pneumonia (5.6%), cardiac failure congestive (5.6%), appendicitis perforated (2.9%), bacteraemia (2.9%).

Safety reporting uses a different set of counts from the primary endpoint population. The registry lists serious adverse events affecting 6 participants in placebo, 7 in TOUR006 25 mg, 6 in TOUR006 50 mg, and 3 in TOUR006 15 mg. The corresponding groups at risk were 36, 35, 35, and 35. The record reports deaths of 0, 1, 1, and 0 in those groups, respectively.

The registry also lists other adverse events affecting 22 participants in placebo, 21 in TOUR006 25 mg, 21 in TOUR006 50 mg, and 21 in TOUR006 15 mg, with the same group-specific counts at risk shown for that measure. These counts describe participants affected, not necessarily the total number of event occurrences. The record does not provide enough detail to interpret event duration, severity beyond the serious-event category, relatedness, or exposure-adjusted rates.

Among the serious-event terms listed, Acute Kidney Injury is reported as 5.7%, Pneumonia as 5.6%, Cardiac Failure Congestive as 5.6%, Appendicitis Perforated as 2.9%, Bacteraemia as 2.9%, and COVID-19 as 2.9%. These entries should be read as registry-reported term frequencies, not as evidence about causation. The counts are descriptive and do not establish comparative safety differences.

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

The posted results show lower time-averaged hs-CRP values in the TOUR006 groups than in the placebo group over the primary endpoint period, with sponsor-reported between-group contrasts and p-values below < 0.001. The estimates describe a biomarker endpoint in the registry-defined modified intention-to-treat population. They do not, by themselves, establish changes in kidney function, cardiovascular events, quality of life, or other clinical outcomes.

A statistically small p-value is not a measure of how important a result is to participants. Nor does a large biomarker contrast establish that a treatment improves health outcomes. The registry record describes the study objectives and endpoint, but it does not report a threshold for clinically meaningful change in hs-CRP or establish how the observed endpoint relates to clinical benefit.

The confidence intervals communicate uncertainty in the estimated comparisons under the analyses used. They do not remove uncertainty arising from the selected analysis population, missing measurements, multiple comparisons, or unreported analysis details. The interpretation is also limited to the reported follow-up and outcomes. A Phase 2 trial with the posted findings cannot answer questions that the registry does not report.

The safety counts should likewise be interpreted descriptively. The registry lists serious adverse events and deaths by group, but the posted counts alone do not establish that an event was caused by study treatment or provide a full comparison of risk. More detailed event definitions, attribution, and exposure information are not reported in the registry record.

Overall, the results support a statistical description of hs-CRP changes during the studied period. They do not establish efficacy for a clinical condition, prove safety, or justify conclusions beyond the measured outcomes and the populations represented in the registry results.

14. Why This Trial Matters Statistically

This trial illustrates why statistical interpretation depends on defining the outcome and analysis population precisely. The primary measure is not a single hs-CRP reading: it summarizes percent change over time using observed assessments from Day 30 to Day 90. Its meaning depends on baseline definition, the observed visits, and the registry’s time-averaging calculation. The stated population also excludes participants who fail specified treatment, baseline, or assessment criteria.

The study compares three dosing schedules with placebo, and the registry reports estimates and uncertainty for each primary contrast. This makes it possible to distinguish the size and precision of the estimated differences from the p-values alone. The different parameter label for the 15 mg contrast is also a reminder that apparently parallel comparisons may not use the same summary statistic.

The registry’s secondary outcomes and safety counts broaden the description of the study, but they raise questions about multiple testing, differing analysis populations, and incomplete reporting. A statistical reading that keeps those limits visible is more informative than treating each small p-value as independent confirmation.

Finally, the sample-size illustrations based on observed effects are not a substitute for a design justification. Distinguishing retrospective planning illustrations from the trial’s original design assumptions avoids confusing an observed result with evidence of adequate prespecified power. The registry record does not report the original sample-size rationale or a complete analysis plan, so those aspects remain uncertain.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary endpoint population is narrower than the overall enrolled population, and its criteria require treatment receipt, a qualifying baseline hs-CRP value, and a minimum level of post-baseline assessment availability. The registry does not report the number excluded for each criterion or provide enough information to assess how exclusions may affect representativeness.

The endpoint depends on observed values and visit timing, but the record does not describe additional missing-data methods or sensitivity analyses. The registry also does not report full model specifications for the quantile-regression comparisons. The 15 mg comparison is labeled a mean difference while the other primary contrasts are labeled median differences, limiting direct comparison of those estimates as if they were identical measures.

Multiple dose comparisons and secondary outcomes are present, but the record does not report a multiplicity strategy. The original sample-size justification and interim-analysis procedures are not reported. These omissions prevent a complete assessment of the design’s inferential plan and the robustness of nominal p-values.

The reported endpoint is a biomarker summary through Day 90, whereas the study schedule extends to Day 150. The posted primary result therefore does not describe the full treatment period or later outcomes. The registry lists safety counts but does not report detailed event attribution, duration, or exposure-adjusted comparisons. The record’s listed secondary outcomes also include objectives for which complete results are not displayed in the posted information.

These are limits of what can be concluded from the registry record. They do not establish that the trial lacked procedures or analyses; details not stated in the record are simply not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Evaluate TOUR006 in Patients With Chronic Kidney Disease and Elevated Hs-CRP — NCT06362759.
• Registry record last updated 2026-08-11; status last verified 2026-07.
• Results first posted 2026-08-11.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT06362759 is a completed, randomized, double-blind, placebo-controlled Phase 2 parallel-group study of TOUR006 in participants with chronic kidney disease and elevated hs-CRP. Enrollment was 143. The primary outcome was time-averaged percent change in hs-CRP through Day 90, assessed in a modified intention-to-treat population.

The registry reports quantile-regression comparisons of each TOUR006 dose with placebo, with p < 0.001 for all three primary contrasts. The arm-level results show more negative median changes for the active groups than for placebo. The 15 mg contrast is labeled a mean difference, while the 25 mg and 50 mg contrasts are labeled median differences.

The record also lists secondary hs-CRP outcomes, pharmacokinetics, safety and tolerability, and adverse-event counts. The original sample-size rationale, multiplicity strategy, interim-analysis details, and additional missing-data methods are not reported in the registry record. The posted findings should be interpreted as statistical results for the stated endpoint and population, not as conclusions about unreported clinical outcomes.