An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access (NCT01806584), a randomized phase 2 study. The primary outcome is Percentage of Participants With Loss of Unassisted Primary Patency.

2. Clinical Question

3. Trial Design

This was a phase 2, randomized, controlled, single-blind, parallel-group, multi-center study. The registry lists Shire as sponsor and records enrollment of 32. The study began on 2013-03-28, had primary completion on 2014-10-23, and its status is terminated. A reason for termination is not reported in the registry record.

Participants were assigned to SRM003 or participating sites’ standard practice. The posted primary outcome results list 18 participants in the SRM003 arm and 14 in the standard-practice arm. The primary outcome population was defined as all randomly assigned participants, regardless of treatment received or availability of post-baseline outcome data. The registry does not report additional details about allocation concealment or the masking procedure, beyond identifying the study as randomized and single-blind.

The primary outcome was the percentage of participants with loss of unassisted primary patency, assessed up to 78 weeks after surgery. Three secondary outcomes were also posted: loss of assisted primary patency, loss of secondary patency, and the number of interventions to establish, maintain, or restore patency. The intervention-count outcome was assessed at 26 weeks after surgery.

The registry does not report the original sample-size justification, the planned statistical analysis details, or whether interim analyses were conducted. Its termination status and enrollment alone do not establish why the study ended or whether the intended recruitment target was reached.

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: The Intent to-Treat (ITT) population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.

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: The Intent-to-Treat population, defined as all randomly assigned participants regardless of the treatment received or having post-baseline outcome data.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Loss of Unassisted Primary Patency, measured over Up to 78 weeks after surgery.

The primary endpoint was the percentage of participants with loss of unassisted primary patency, assessed up to 78 weeks after surgery. Unassisted primary patency was defined as intervention-free access survival. The registry measured the duration from randomization, which it identifies with arteriovenous graft placement, until the first qualifying event: an intervention intended to establish, maintain, or restore patency; occlusion, commonly due to thrombosis; or access abandonment.

This endpoint captures whether the graft remains available without an intervention to restore or maintain patency, as well as whether it becomes occluded or is abandoned. It is relevant to the study’s stated objective of evaluating duration of primary patency after graft surgery. Counting several types of failure in one endpoint can provide a broader measure of access loss, but the events are not identical; the registry’s definition is needed to understand what the reported percentages represent.

Patency was assessed at visits through physical examination and ongoing monitoring and surveillance according to each participating site’s standard practice. The registry recommended following National Kidney Foundation Kidney guidelines on management and treatment of graft complications. The reported endpoint is a percentage with loss, not a direct estimate of the duration of patency for each participant.

7. Results Posted in the Registry

• SRM003: 66.7% (12/18) versus 35.7% (5/14) on control; risk difference 31.0 percentage points (95% CI -2.3 to 64.2), risk ratio 1.87 (0.86–4.05); unadjusted two-proportion z-test p = 0.082.

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.

Percentage of Participants With Loss of Assisted Primary Patency

• 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:
  • SRM003: 55.6% (10/18) versus 28.6% (4/14) on control; risk difference 27.0 percentage points (95% CI -6.0 to 60.0), risk ratio 1.94 (0.77–4.91); unadjusted two-proportion z-test p = 0.127.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SRM003 and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants With Loss of Secondary Patency

• 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:
  • SRM003: 27.8% (5/18) versus 7.1% (1/14) on control; risk difference 20.6 percentage points (95% CI -4.1 to 45.3), risk ratio 3.89 (0.51–29.62); unadjusted two-proportion z-test p = 0.138.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SRM003 and the control. The interval gives the range of effects that remain compatible with the data.

Number of Interventions to Establish, Maintain, or Restore Patency

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • SRM003: mean 0.90 versus 0.70 on control; difference 0.20 (95% CI -1.02 to 1.42), standardized effect d = 0.12; z-test p = 0.748.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SRM003 and the control. The interval gives the range of effects that remain compatible with the data.

Across the secondary outcomes, the direction of the observed comparisons is broadly similar to the primary endpoint: each reported loss-of-patency percentage is higher in the SRM003 arm than in the standard-practice arm, and the reported mean number of interventions is also higher in the SRM003 arm. The secondary outcomes address related but different aspects of access patency, so they provide context rather than a direct replication of the primary endpoint.

The posted results do not establish a clear treatment effect across these outcomes. The sponsor-reported log-rank p-values for the secondary patency outcomes are 0.312 and 0.093; for the intervention count, the sponsor reports a mean treatment difference of 0.230 with a 95% confidence interval from -0.942 to 1.402. These findings should be considered with the primary result’s imprecision and the small study size. In particular, outcome definitions and assessment periods differ: the patency outcomes are reported up to 78 weeks after surgery, while the intervention count is reported at 26 weeks after surgery.

Unadjusted secondary analyses carry less weight than the prespecified primary question because multiple outcomes create more opportunities for apparently notable results by chance. The registry record does not report a multiplicity plan or state whether any adjustment was made. Secondary outcomes can help describe the pattern and generate questions for further study, but they should not be treated as independent confirmation of a primary finding. The overall pattern is descriptive and does not resolve uncertainty about comparative effects.

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

• Percentage of Participants With Loss of Assisted Primary Patency
• Percentage of Participants With Loss of Secondary Patency
• Number of Interventions to Establish, Maintain, or Restore Patency

9. Statistical Interpretation

10. Statistical Methods Explained

The posted primary outcome is a binary event measure: a participant either had a recorded loss of unassisted primary patency during the stated period or did not. The registry reports the percentage with the event in each arm. A difference between percentages is a risk difference. In this comparison, a positive risk difference means a higher observed event proportion in the SRM003 arm than in the standard-practice arm, because the endpoint is loss of patency.

What does the risk difference describe?

The unadjusted recalculation reports a risk difference of 0.309. This is an absolute contrast between the observed arm proportions, not a relative measure. Its confidence interval runs from -0.023 to 0.642. A value of zero represents no difference in event proportions; negative values represent a lower event proportion in the SRM003 arm, and positive values represent a higher event proportion. The interval spans both directions, so it does not pin down a single direction or a narrow effect size.

The registry also reports relative comparisons, including a risk ratio of 1.867 with an interval from 0.86 to 4.052, and an odds ratio of 3.6 with an interval from 0.829 to 15.63. A risk ratio compares event proportions as a ratio, while an odds ratio compares event odds. These measures answer different questions from an absolute risk difference and can be less intuitive to interpret. Their wide intervals reflect substantial uncertainty in the estimate. The measures should not be substituted for one another.

Why is there a log-rank result as well?

The endpoint definition starts at randomization and identifies the time until the first qualifying event. For outcomes recorded over time, a log-rank test compares the event-time patterns between groups, using the ordering of events and accounting for participants who have not had a recorded event by the end of their observed follow-up. The registry reports a log-rank p-value of 0.138 for the primary outcome, but no effect estimate or confidence interval for that analysis. A p-value indicates how compatible the data are with a specified no-difference model under the method used; it is not a measure of effect size, the probability that a treatment works, or a measure of clinical importance.

The recalculated p-value of 0.082 comes from an unadjusted comparison of the posted summary proportions, not from the reported log-rank method. Different methods can give different p-values because they use the data differently and may target different summaries. The registry does not report enough detail about its log-rank analysis to reconstruct its full time-to-event estimates. Consequently, the log-rank result should be read as the sponsor-reported analysis, while the recalculation is a separate, simple summary comparison.

Why can over-dispersion matter?

For count outcomes, a simple statistical model can assume that variation is governed by the mean count. If the observed variation is larger than that assumption allows, the data are over-dispersed. Standard errors may then be too small under an inadequate model, making intervals too narrow and tests too optimistic. This is a general statistical concern for count data. The posted intervention outcome is a count of interventions, but the registry does not report a count model or an over-dispersion assessment. Its reported mean treatment difference and confidence interval should therefore be understood through the analysis that was posted, not through an unreported model assumption.

What is the role of the confidence interval?

A confidence interval describes the uncertainty around an estimate under the statistical method used. Narrower intervals indicate greater precision; wider intervals indicate less precision. For the primary risk difference, the reported interval extends from a small negative value to a positive value substantially larger than the point estimate. This means the posted summary data do not identify the size of the difference precisely. The interval is not a range containing every plausible individual outcome, and it does not resolve whether the result is important in clinical practice.

The primary result is based on a small randomized study, and the posted event proportions are based on the participants listed for each arm. The registry does not report details about missing outcome data, censoring, or sensitivity analyses. Those details matter because incomplete observation can affect estimates, particularly for an outcome defined over time. The ITT definition states who belongs to the analysis population, but does not by itself explain how unavailable endpoint information was handled.

11. Confidence Intervals and Precision

The primary unadjusted risk difference is 0.309, and its confidence interval extends from -0.023 to 0.642. The width of this interval signals limited precision: values ranging from a slight difference in the opposite direction to a considerably larger positive difference remain compatible with the recalculated estimate under its method. Since zero lies within the interval, the posted data do not precisely establish the direction of the absolute difference.

The arm percentages are 66.7% for SRM003 and 35.7% for participating sites’ standard practice. Those point estimates give a direct descriptive account, but they should not be read without their uncertainty. The relative estimates are also imprecise: the risk ratio is 1.867 with an interval from 0.86 to 4.052, and the odds ratio is 3.6 with an interval from 0.829 to 15.63. Intervals for relative measures have their own scale and interpretation, so they are not directly comparable in width to the risk-difference interval.

The registry’s log-rank analysis reports p = 0.138 but no confidence interval or time-to-event effect estimate. Thus, precision for the sponsor-reported time-to-event comparison cannot be assessed from an interval in the registry record. A p-value alone cannot show which effect sizes are compatible with the data. Overall, the small posted arm sizes and broad intervals counsel against treating the point estimates as stable or definitive.

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 sample-size illustration uses the observed primary outcome effect as its starting point and asks how many participants per arm would be needed under specified planning assumptions. Because the primary outcome is presented as a percentage of participants with an event, these entries are participants per arm, not total events. For time-to-event outcomes, the convention in the planning material is instead to report the total number of events; that distinction does not change the interpretation of the primary binary-outcome entries.

The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers an effect to detect that is a stated fraction of the observed effect. The columns for 80% and 90% power describe the number of participants per arm that the planning calculation indicates would be needed to have those respective chances of detecting the assumed effect, if the assumptions and effect size were correct. They are planning targets, not observed results.

The illustration gives 40 participants per arm for 80% power and 53 participants per arm for 90% power when planning for 100% of the observed effect. When planning for 75% of the observed effect, the corresponding entries are 72 and 96; for 50% of the observed effect, they are 160 and 214. The pattern is expected: smaller effects are harder to detect, so planning to detect a smaller effect requires more participants. These calculations are not observed power and should not be interpreted as evidence about the probability that the completed study detected an effect. The registry’s original sample-size rationale and design assumptions are 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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.357; treatment proportion p₁ = 0.667; average p̄ = 0.512.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7069 = 1.3855.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6722 = 0.5657.
4. n = (1.3855 + 0.5657)² / (0.3095)² = 39.7, rounded up to 40 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
p0 <- 0.357142857142857                          # control proportion
p1 <- 0.666666666666667                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1806584)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 40 (80% power), 53 (90% power)
 75% of observed effect: n per arm = 72 (80% power), 96 (90% power)
 50% of observed effect: n per arm = 160 (80% power), 214 (90% power)
power.prop.test: 39.7 
Simulated power at n = 40 per arm: 0.819 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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 a log-rank analysis for the primary endpoint, with p = 0.138. This is the sponsor-reported time-to-event comparison. It is distinct from the recalculated unadjusted comparison of the posted event percentages, which gives a risk difference of 0.309, a confidence interval from -0.023 to 0.642, and p = 0.082.

The two p-values differ because the calculations do not use the same analysis method. The log-rank test compares event-time patterns; the simple recalculation compares the posted proportions. The registry does not report a log-rank effect estimate or interval, so the reported p-value cannot be used to quantify the time-to-event difference or its precision. The recalculation is useful as a transparent descriptive check on the displayed event percentages, but it is not a replacement for the sponsor’s analysis.

The registry record does not flag a discrepancy between its posted results and the recalculation. Neither p-value should be read as a probability that SRM003 is effective or ineffective. The results are best interpreted alongside the endpoint definition, the observed arm percentages, the uncertainty around the recalculated difference, and the limitations of the record’s reporting.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and three secondary outcomes. Testing several outcomes can increase the chance of observing an apparently notable result even when there is no underlying effect. Statistical methods can address this through a prespecified hierarchy or adjustment, but a multiplicity plan is not reported in the registry record. The posted secondary analyses should therefore be read as exploratory context rather than as a set of confirmatory tests that independently establish effects.

The primary population is described as intent-to-treat: all randomly assigned participants, regardless of treatment received or whether post-baseline outcome data were available. This definition helps preserve the randomized comparison, but it does not indicate how missing endpoint measurements were handled. Details on missingness, censoring, imputation, exclusions from specific analyses, or sensitivity analyses are not reported in the registry record.

These omissions matter for a patency outcome assessed over time. Participants may have different lengths of observation, and the handling of participants without a recorded event can affect time-to-event estimates. The log-rank result is reported, but the registry does not provide the underlying event-time summaries, censoring information, or an effect estimate with an interval. As a result, readers cannot fully assess how incomplete follow-up or missing outcome information influenced that analysis.

The registry also does not report the original statistical analysis plan, planned interim analyses, or the study’s original sample-size justification. The available record supports interpretation of the posted outcomes and analyses, but not a reconstruction of all prespecified decisions or a judgment about whether the reported analyses were the only ones conducted.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: fluid overload (14.3%), dyspnoea (14.3%), arteriovenous graft site infection (11.1%), steal syndrome (11.1%), acute myocardial infarction (7.1%).

The safety record lists serious adverse events affecting 10 participants in each arm. The numbers at risk for serious adverse events are 14 for standard practice and 18 for SRM003. Other adverse events are listed for 13 participants in the standard-practice arm and 17 in the SRM003 arm, with those same arm sizes shown as the numbers at risk. These are participant counts, not event rates adjusted for exposure time, and they do not by themselves establish a comparative safety effect.

The registry lists fluid overload and dyspnoea at 14.3% each, arteriovenous graft site infection and steal syndrome at 11.1% each, and acute myocardial infarction and atrial fibrillation at 7.1% each among the top serious adverse-event terms. The record does not assign these listed terms to a specific arm in the posted summary. Death counts are not reported in the registry record.

These figures describe events recorded in a small study. They cannot establish whether an event was caused by an intervention, and the absence of a listed term would not prove that no such event occurred. The registry record does not provide further detail on event severity categories, exposure-adjusted rates, or causal assessments.

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

The study provides a randomized comparison of SRM003 with participating sites’ standard practice after arteriovenous graft surgery. For the primary endpoint, the posted percentage with loss of unassisted primary patency is higher in the SRM003 arm than in the standard-practice arm. The unadjusted estimate is imprecise, and the registry’s log-rank analysis reports p = 0.138. Together, these results describe the observed data but do not establish a reliable direction or magnitude of effect.

The endpoint combines several events: intervention to establish, maintain, or restore patency, occlusion, or access abandonment. It is therefore a measure of loss of intervention-free access survival rather than a direct measure of any single complication. The registry’s assessment approach included physical examination and site-standard monitoring, so outcome ascertainment was tied in part to participating-site practice.

The study’s termination status, enrollment of 32, lack of a reported termination reason, and unreported design assumptions limit what can be inferred about how the trial was intended to proceed. The posted results do not establish the results that would occur in a larger study, under different site practices, or in a different population. They also do not show that SRM003 caused the observed arm differences.

Safety counts add descriptive information but do not establish comparative risk or causality. Similarly, secondary outcomes offer context but are subject to the uncertainty and multiplicity concerns. The record should be read as a limited account of a small trial’s observed outcomes, not as a definitive answer about efficacy or safety.

18. Why This Trial Matters Statistically

This trial illustrates why the choice of endpoint and analysis method matters. Loss of unassisted primary patency is defined by a composite of intervention, occlusion, or access abandonment and is assessed over time. The registry reports both percentages with loss and a log-rank comparison, but the summary proportions and time-to-event test are not identical analyses. Reporting an effect estimate and confidence interval for the time-to-event analysis would make its size and precision easier to assess.

It also illustrates the distinction between a point estimate and the uncertainty around it. The observed arm percentages differ, but the recalculated confidence interval for the risk difference spans both sides of zero. The data do not support a narrow conclusion about the direction or size of the underlying difference. A p-value alone cannot resolve that uncertainty.

The posted secondary outcomes and safety counts show why studies need clear prespecified outcome and multiplicity plans. Multiple related outcomes can offer useful context, but they do not all carry the same evidential weight. For a small, terminated study with unreported design assumptions and limited analysis detail, careful separation of descriptive findings from confirmatory conclusions is particularly important.

For clinical researchers, the record demonstrates the value of complete reporting: reasons for termination, missing-data handling, analysis populations, time-to-event estimates, and sample-size rationale all help readers judge how much confidence to place in a result. Their absence does not invalidate the posted numbers, but it limits the inferences that can be drawn from them.

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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The trial enrolled 32 participants and is recorded as terminated. The reason for termination is not reported in the registry record, so the status cannot be interpreted as evidence about the outcomes or the reason recruitment stopped. The record also does not report the intended recruitment target or original sample-size justification.

The registry provides a log-rank p-value for the primary outcome but no time-to-event effect estimate or confidence interval. Missing-data and censoring details are not reported, limiting assessment of how incomplete follow-up may have influenced the time-to-event result. The posted recalculation is an unadjusted comparison of summary proportions and does not substitute for fuller participant-level time-to-event analysis.

Single-blind masking is recorded, but the registry does not describe who was masked or how masking was maintained. The standard-practice comparator is site-specific, and the record does not detail the practices used at each site. Patency assessment included monitoring according to site practice, which may make consistency of assessment difficult to evaluate from the registry summary.

The registry does not report the statistical analysis plan, multiplicity handling, interim analyses, or details of missing outcome data. It also does not report a reason for termination, and deaths are not reported in the safety record. These omissions restrict evaluation of bias, precision, and the completeness of the posted analysis. The results are therefore best treated as limited descriptive and inferential evidence from the recorded study.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Placement of an Arteriovenous Graft to Facilitate Hemodialysis Access — NCT01806584.
• Registry record last updated 2021-06-08; status last verified 2021-05.
• Results first posted 2015-12-31.
• 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

The registry describes a terminated phase 2, randomized, controlled, single-blind, multi-center, parallel-group study of SRM003 versus participating sites’ standard practice after arteriovenous graft surgery for hemodialysis access. Enrollment was 32, with primary completion on 2014-10-23. The primary endpoint was the percentage with loss of unassisted primary patency up to 78 weeks after surgery.

The posted primary percentages were 66.7% for SRM003 and 35.7% for standard practice. The unadjusted risk difference was 0.309, with a confidence interval from -0.023 to 0.642; the registry reports a log-rank p-value of 0.138. The results are imprecise and do not establish a treatment effect. The reason for termination, original sample-size rationale, detailed missing-data handling, and multiplicity plan are not reported in the registry record.