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 An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria (NCT03938272), a na phase 3 study. The primary outcome is Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03938272 |
| Phase | Phase 3 |
| Condition | Hyperoxaluria, Primary |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OxThera |
| Results posted | Yes |
2. Clinical Question
Population
Patients with primary hyperoxaluria who completed study OC5-DB-02 were eligible for this open-label extension. The primary endpoint population was patients with at least one efficacy measurement during the open-label period. The registry reports enrollment of 22, but does not report how many participants contributed to each endpoint analysis.
Intervention
Participants received Oxabact OC5, described as Oxalobacter formigenes Strain HC-1. This was an open-label extension, so participants and investigators were not masked to treatment. The registry record does not report a separate treatment group or a concurrent control arm for this extension.
Comparator
The study is listed as single-group, with no randomized allocation. The primary question is therefore about changes from baseline during treatment, not a randomized comparison against placebo or another treatment. Earlier double-blind study assignments are mentioned when describing baseline values, but do not create a concurrent control comparison in this extension.
Primary question
The primary endpoint is change from baseline in estimated glomerular filtration rate, or eGFR, after 12 and 24 months of open-label Oxabact treatment. The registry gives a timeframe of 104 weeks. Numerical estimates of change and their uncertainty are not reported in the registry record, so the magnitude and precision of the endpoint result cannot be assessed.
In practical statistical terms, the question is whether kidney-function measurements in participants during the extension differed from the defined baseline measurements. That is a within-participant change question. It is not, by itself, an estimate of what would have happened to the same participants over the same period without Oxabact.
The baseline definition depended on participants’ previous study experience. For those treated with Oxabact in the double-blind study, baseline was before treatment in that study. For those who received placebo there, baseline was taken in the extension, after 48 to 52 weeks in the double-blind study. These differing reference points matter when interpreting a pooled change-from-baseline summary.
3. Trial Design
This was a Phase 3, open-label, single-group treatment extension sponsored by OxThera. Its stated purpose was to evaluate long-term efficacy and safety of Oxabact in patients with primary hyperoxaluria who completed study OC5-DB-02. The intervention is identified as Oxabact OC5 capsules containing Oxalobacter formigenes Strain HC-1. Because the study was open-label, treatment assignment was not masked.
The registry lists enrollment of 22 and status as terminated. The recorded study start was 2019-03-14, and primary completion was 2021-07-14. Those administrative details describe the study record; they do not explain the reason for termination, which is not reported in the registry record.
A single-group extension follows participants receiving treatment rather than assigning participants concurrently to different randomized groups. This design can describe measurements and events observed during follow-up. It cannot, on its own, separate treatment-related change from changes associated with time, participants’ prior study histories, or other factors that may influence measurements. Open-label status can also affect how participants and investigators report or assess outcomes, depending on the outcome and collection procedures.
The primary endpoint is a continuous measure, change from baseline in eGFR, with a stated timeframe of 104 weeks. The endpoint description refers to change after 12 and 24 months of treatment. A secondary outcome is change from baseline in plasma oxalate concentration. The registry lists two outcome measures but does not report analysis results for them. The number of analyses reported is zero.
The registry record does not report a concurrent control group, a randomization procedure, masking, the treatment schedule, or details of monitoring and follow-up beyond the endpoint timeframe. These omissions limit how fully the design and the practical meaning of long-term exposure can be reconstructed from the record alone. The prior double-blind study is relevant to the history of the participants and the definition of baseline, but this extension should not be read as a continuation of a randomized comparison.
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
| Stage | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex |
|---|---|---|
| STARTED | 11 | 11 |
| COMPLETED | 0 | 1 |
| NOT COMPLETED | 11 | 10 |
Reasons for not completing this period:
| Reason | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex |
|---|---|---|
| Withdrawal by Subject | 1 | 0 |
| Physician Decision | 0 | 2 |
| Study termination by sponsor | 10 | 8 |
Analysis population for the primary outcome, as defined in the registry: Patients with at least one efficacy measurement in the open-label period
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 | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placebo in ePHex | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 11 | 22 | |
| Age, Categorical: <=18 years | Participants | 7 | 8 | 15 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 | 3 | 7 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 14.0 (SD 6.9) | 17.1 (SD 14.2) | 15.5 (SD 11.0) |
| Sex: Female, Male: Female | Participants | 8 | 4 | 12 |
| Sex: Female, Male: Male | Participants | 3 | 7 | 10 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 10 | 11 | 21 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: Belgium | participants | 0 | 2 | 2 |
| Region of Enrollment: United Kingdom | participants | 1 | 1 | 2 |
| Region of Enrollment: Germany | participants | 2 | 4 | 6 |
| Region of Enrollment: Spain | participants | 5 | 2 | 7 |
| Region of Enrollment: Tunisia | participants | 3 | 1 | 4 |
| Region of Enrollment: United States | participants | 0 | 1 | 1 |
| Primary hyperoxaluria diagnosis: PH Type I | Participants | 11 | 10 | 21 |
| Primary hyperoxaluria diagnosis: PH Type II | Participants | 0 | 1 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Kidney Function (eGFR) After 12 and 24 Months of Open-label Oxabact Treatment, measured over 104 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mL/min/1.73 m2 |
| Endpoint classification | Continuous Endpoint |
The primary endpoint measures change from baseline in estimated glomerular filtration rate, abbreviated eGFR, in mL/min/1.73 m2. eGFR is a continuous measure used to characterize kidney function. A change score expresses how an individual’s follow-up measurement differs from the reference measurement chosen as baseline. The registry specifies assessments after 12 and 24 months of open-label treatment and gives the overall timeframe as 104 weeks.
Using a continuous measure can retain information about the degree of change rather than reducing outcomes to broad categories. A mean change summarizes the average direction and magnitude of the observed changes in the analysis population. The registry identifies the endpoint parameter as a mean and its dispersion measure as a standard deviation. A standard deviation describes variation among individual measurements; it does not by itself show how precisely the mean has been estimated.
The baseline definition is important. Participants previously treated with Oxabact in the double-blind study use a baseline before treatment in that study. Participants previously treated with placebo use an extension-study baseline after 48 to 52 weeks in the double-blind study. Thus, a shared label of change from baseline does not mean every participant’s reference measurement was taken at the same point in their study history.
The registry does not report the mean change, standard deviation, participant count contributing to each time point, confidence interval, or test result. Accordingly, the endpoint’s observed direction, size, and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a clinically relevant type of question—whether eGFR changed during an extended period of open-label treatment—but does not include numerical primary-endpoint results. It reports the endpoint definition, measurement unit, summary parameter, dispersion measure, timeframe, and analysis-population description. It does not report the observed mean change or standard deviation at either stated follow-up point. It also does not report confidence intervals, p-values, or the number of participants contributing measurements to each analysis.
Without those results, readers cannot determine from the registry record whether the average change was positive, negative, or close to zero, nor how variable individual changes were. There is no basis for judging whether any observed change was estimated precisely. Even if a mean and standard deviation were displayed elsewhere, precision of the mean would require information about the analysis population and the method used to calculate uncertainty. A standard deviation alone describes spread among observations, not the uncertainty around the mean.
The design further shapes interpretation. A single-group extension can describe what happened to participants while they were followed and treated, but it does not estimate a randomized treatment contrast. A before-and-after change can reflect treatment, the passage of time, prior treatment history, changes in clinical circumstances, or measurement variability. Without a concurrent comparison group, those explanations cannot be distinguished by the design alone.
The baseline definition also varies according to earlier assignment in OC5-DB-02. For participants who received Oxabact in that earlier study, the reference was before treatment there; for participants who received placebo, the reference was taken in the extension after 48 to 52 weeks in the earlier study. The registry does not report separate endpoint estimates by prior assignment, so it is not possible to assess whether those histories corresponded to different trajectories.
The safety information reports serious adverse events in the two listed groups, with 11 participants at risk in each. The record lists 3 affected participants in one group and 1 in the other, and reports 0 deaths in each. These are descriptive counts. The group labels refer to earlier study assignment, and this extension is not a randomized comparison; the figures should not be interpreted as evidence of a treatment difference. The record also does not provide enough detail to establish whether the groups are suitable for direct comparison or whether the listed events overlap across categories.
In short, the record describes the intended endpoint and some safety counts, but it does not report the efficacy estimates needed to characterize the observed eGFR changes. The absence of reported analysis results is not evidence that no change occurred; it means the direction, magnitude, and precision cannot be established from this registry record.
9. Statistical Methods Explained
This discussion distinguishes what the registry says about the analysis from general statistical interpretation. The endpoint is continuous, summarized as a mean with standard deviation, and defined as change from baseline in eGFR. The registry record does not report the statistical model, confidence-interval method, hypothesis test, handling of repeated measurements, or exact analysis procedure. No specific inferential method should therefore be attributed to the study.
What does a change-from-baseline mean represent?
A change score is calculated by comparing a follow-up measurement with a participant’s reference measurement. A mean change then summarizes the changes across the participants included in an analysis. This can be an intuitive summary of the average trajectory, but it does not show how every participant changed. Some participants may have changes above the mean and others below it. The standard deviation is a summary of how spread out the individual observations are around their mean.
In this study, the registry describes a baseline that depends on earlier study treatment. That makes the meaning of the change score specific to each participant’s study history. An average across participants with differently timed reference measurements can be useful as a descriptive summary, but its interpretation depends on understanding those reference points. The record does not report baseline distributions or separate summaries by prior study assignment.
How should standard deviation and precision be distinguished?
General statistical explanation: a standard deviation describes variation among the observed values. A confidence interval, when reported, describes uncertainty around an estimated quantity under the assumptions of the method used. The two answer different questions. A broad range of participant values can coexist with a precisely estimated mean if there is sufficient information, while a small standard deviation does not automatically establish precise estimation. The registry gives the dispersion measure but does not report a confidence interval or the number analyzed at each assessment.
Because the endpoint results are not reported, readers cannot assess how much uncertainty surrounds the mean change. Nor can they determine whether an analysis used a confidence interval, a model-based standard error, or a test against a particular reference value. Those details are not reported in the registry record.
What can a single-group design estimate?
General statistical explanation: a single-group study estimates observed outcomes in the participants who were followed, subject to the chosen analysis and missing-data assumptions. A randomized concurrent control group supports a different estimand: a contrast between outcomes under different assigned treatments, with randomization helping balance measured and unmeasured factors on average. This extension has no concurrent randomized control group. Its change-from-baseline summaries, if available, would describe within-group change and should not be presented as a randomized treatment effect.
Change over time can have multiple explanations. Natural variation, clinical events, prior treatment, and changes in measurement or follow-up can contribute. In an uncontrolled extension, statistical adjustment cannot automatically recover the missing counterfactual outcome. The registry does not describe an adjusted analysis or a causal identification strategy.
What does the planning illustration mean?
The sample-size section on this page is a planning illustration based on the observed effect, not the trial’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, its results are expressed as participants per arm for 80% power or other displayed planning targets. These assumptions describe the illustration, not this extension trial, which is listed as single-group.
General statistical explanation: a planning calculation asks how much information a hypothetical future design might require to detect a chosen effect under stated assumptions. It depends on the effect size, variability, allocation, test, and target power. A calculation based on an observed effect can be especially sensitive to how that effect was estimated. Such a planning result is not observed power, does not describe how many participants the extension actually needed, and does not establish that its endpoint result is statistically significant. The registry does not report a trial-specific sample-size justification.
Why is a test result not enough on its own?
General statistical explanation: a p-value, if reported, measures how compatible the data are with a specified null model under the assumptions of the test. It does not quantify the probability that a treatment works, and it does not measure the size or clinical importance of an effect. Effect estimates and uncertainty intervals are needed to communicate magnitude and precision. Here, no p-value or numerical effect estimate for the primary endpoint is reported in the registry record.
Repeated assessments can also require a clear analysis plan. A model may account for correlations among repeated measurements, or an analysis may summarize change at specified time points. Which approach is appropriate depends on the data and planned estimand. The registry identifies the 12- and 24-month endpoint and a 104-week timeframe, but does not report the model, covariance assumptions, or how measurements outside scheduled visits were handled. Those choices cannot be inferred from the endpoint description.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary endpoint of change from baseline in eGFR after 12 and 24 months and a secondary outcome of change from baseline in plasma oxalate concentration. It reports two outcome measures, but no analyses. Because the primary endpoint refers to more than one follow-up point and another outcome is listed, a complete interpretation would benefit from knowing which comparisons were confirmatory and how the analysis plan handled multiple opportunities to test a hypothesis. The multiplicity strategy is not reported in the registry record.
General statistical explanation: when several outcomes, time points, or subgroup comparisons are tested, the chance of at least one apparently unusual result can increase if each test is treated independently at the same threshold. Possible approaches include defining a primary time point, sequencing tests, adjusting significance thresholds, or emphasizing estimation and confidence intervals. These are general options, not methods that can be attributed to this study.
The primary analysis population is described as patients with at least one efficacy measurement in the open-label period. That definition excludes participants without any such measurement from the endpoint population, but the registry does not report how many participants met the criterion or how many were missing at each time point. It also does not report reasons for missing measurements, whether participants discontinued, or how missing data were handled.
General statistical explanation: missing outcomes can affect an estimate when the probability of a measurement being unavailable is related to participants’ health, treatment experience, or unobserved outcome values. Complete-case summaries describe those with observed measurements and may not represent everyone enrolled if missingness is informative. Methods such as imputation or likelihood-based modeling require assumptions and details about implementation; none are reported. The record also does not report whether sensitivity analyses assessed the influence of missing data.
Without those details, the analysis population, missing-data assumptions, and multiplicity control cannot be evaluated. This does not establish that the study used an inappropriate approach; it marks what cannot be determined from 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 |
|---|---|---|---|
| Oxabact OC5 Capsules; OC5 in ePHex | 3 | 11 | 27.3% |
| Oxabact OC5 Capsules; Placeob in ePHex | 1 | 11 | 9.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Oxabact OC5 Capsules; OC5 in ePHex | 0 of 11 |
| Oxabact OC5 Capsules; Placeob in ePHex | 0 of 11 |
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 |
|---|---|
| Oxabact OC5 Capsules; OC5 in ePHex | 7 of 11 |
| Oxabact OC5 Capsules; Placeob in ePHex | 8 of 11 |
Most frequent serious adverse event terms
| Event term | Organ system | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placeob in ePHex |
|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | 1 of 11 | 1 of 11 |
| Renal colic | Renal and urinary disorders | 0 of 11 | 1 of 11 |
| Pyrexia | General disorders | 1 of 11 | 0 of 11 |
| Pyelonephritis | Infections and infestations | 1 of 11 | 0 of 11 |
| Pyelonephritis acute | Infections and infestations | 1 of 11 | 0 of 11 |
| Burns second degree | Injury, poisoning and procedural complications | 1 of 11 | 0 of 11 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Oxabact OC5 Capsules; OC5 in ePHex | Oxabact OC5 Capsules; Placeob in ePHex |
|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | 2 of 11 | 2 of 11 |
| Pyrexia | General disorders | 4 of 11 | 0 of 11 |
| Headache | Nervous system disorders | 1 of 11 | 3 of 11 |
| COVID-19 | Infections and infestations | 0 of 11 | 3 of 11 |
| Urinary tract infection | Infections and infestations | 2 of 11 | 1 of 11 |
| Flank pain | Musculoskeletal and connective tissue disorders | 1 of 11 | 2 of 11 |
| Pharyngotonsillitis | Infections and infestations | 2 of 11 | 0 of 11 |
| Abdominal pain | Gastrointestinal disorders | 1 of 11 | 1 of 11 |
| Abdominal pain upper | Gastrointestinal disorders | 2 of 11 | 0 of 11 |
| Diarrhoea | Gastrointestinal disorders | 1 of 11 | 1 of 11 |
Serious events with the highest arm-level rate: nephrolithiasis (9.1%), renal colic (9.1%), pyrexia (9.1%), pyelonephritis (9.1%), pyelonephritis acute (9.1%).
The safety display lists two groups of Oxabact OC5 capsule recipients identified by their earlier assignment in the double-blind study. Each group reports 11 participants at risk. The first lists 3 participants with a serious adverse event and 7 with an other adverse event; the second lists 1 participant with a serious adverse event and 8 with an other adverse event. Both list 0 deaths.
These are counts reported for the displayed groups, not a randomized comparison of treatment during this extension. The group labels refer to Oxabact or placebo in the earlier study, while the extension itself is listed as open-label and single-group. The counts should be read descriptively rather than as an estimate of a causal difference between treatments. The registry does not report definitions for the categories in enough detail to resolve how the serious and other-event counts relate to one another.
The listed serious-event terms each have a reported frequency of 9.1%: nephrolithiasis, renal colic, pyrexia, pyelonephritis, acute pyelonephritis, and second-degree burns. The record does not give event-level timing, duration, severity beyond the serious classification, attribution, or whether a participant experienced more than one listed term. These details should not be inferred from the term list.
Zero deaths in the displayed groups means none are listed for these groups in the registry results. It does not by itself summarize all possible safety outcomes or establish the absence of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that this was an open-label extension intended to follow patients with primary hyperoxaluria who completed OC5-DB-02, and that its primary endpoint concerned change in eGFR during treatment. It also gives a population definition, endpoint units, a timeframe, an outcome summary type, and selected safety counts. Those details are useful for understanding what the study set out to describe.
However, the primary endpoint’s numerical results are not reported in the registry record. There is no mean change, standard deviation, confidence interval, p-value, or analysis count to support a conclusion about the direction or size of the observed eGFR change. The record therefore cannot establish how precisely kidney-function change was estimated. This is a limit of the information, not a finding that the measurement was unchanged.
Even with numerical before-and-after results, a single-group extension would not provide a randomized comparison against an untreated or alternative-treatment group. An observed change could reflect treatment or other influences over time. The different baseline definitions, depending on prior study assignment, add context that would need to be considered in any pooled description.
The safety counts provide a descriptive account of events in two groups defined by earlier study assignment. They do not support a causal comparison in this extension. The registry also does not provide the event-level details needed to assess timing, attribution, or overlap among categories.
Thus, the result that can be stated from this record is limited: the study was designed to assess long-term eGFR change and safety, but numerical efficacy analyses are not reported. Readers should not treat the study design, endpoint definition, or planning illustration as substitutes for the missing estimates. Nor should the absence of posted results be interpreted as evidence for or against a treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically instructive because its extension design highlights the difference between describing change and estimating a comparative treatment effect. A participant’s eGFR can be measured before and during treatment, and the resulting changes can be summarized. But without a concurrent randomized comparison, those changes do not isolate what would have occurred under another treatment or without treatment.
The endpoint’s baseline definition also shows why time origin matters. Some participants’ baseline was before treatment in the double-blind study, while others’ baseline was set in the extension after 48 to 52 weeks in the earlier study. A baseline label can conceal different histories unless the analysis and interpretation make those histories clear.
The record also illustrates that endpoint descriptions and endpoint results are different kinds of information. It specifies the measure, units, timeframe, mean parameter, standard deviation, and analysis-population criterion, but the numerical estimates and uncertainty are not reported. Without them, readers cannot assess magnitude, precision, or the contribution of participants with missing follow-up.
Finally, planning calculations should be separated from trial design and observed findings. The sample-size section is a planning illustration based on an observed effect and hypothetical two-arm assumptions. That is not a description of this single-group extension’s design and is not evidence about the strength of its results. Keeping those distinctions clear prevents design assumptions, descriptive findings, and future-study planning from being conflated.
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.
Several limitations are specific to interpreting this extension from the registry record. First, the primary endpoint results are not reported. The record does not give mean changes, standard deviations, confidence intervals, p-values, or time-point analysis counts. The central efficacy question therefore cannot be answered numerically from this record.
Second, the extension is open-label and single-group, with no concurrent randomized control. Any change from baseline is descriptive and cannot, by itself, distinguish treatment-associated change from other changes over time. The record does not report an adjustment strategy that would address this limitation.
Third, baseline timing varies according to participants’ earlier assignment in OC5-DB-02. The registry does not report separate endpoint estimates for these prior-assignment groups, or enough detail to evaluate how combining the different reference points affects interpretation.
Fourth, the endpoint population includes patients with at least one efficacy measurement during the open-label period, but the number analyzed and the amount and pattern of missing follow-up are not reported. The registry also does not report how missing measurements were handled or whether sensitivity analyses were conducted.
Finally, the record does not report the statistical model, analysis of repeated measures, multiplicity approach, trial-specific sample-size justification, or reason for termination. Those details are needed to evaluate the analysis plan and the context of the reported status. Their absence from this record should not be taken as evidence about what may have been specified elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Extension Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria — NCT03938272.
- Registry record last updated 2021-12-08; status last verified 2021-11.
- Results first posted 2021-12-08.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This Phase 3 study was an open-label, single-group extension of Oxabact OC5 for patients with primary hyperoxaluria who completed OC5-DB-02. The registry lists enrollment of 22, sponsor OxThera, and status as terminated. The recorded study start was 2019-03-14, with primary completion on 2021-07-14.
The primary endpoint was change from baseline in eGFR after 12 and 24 months, with a timeframe of 104 weeks. The endpoint was defined as a mean with standard deviation, in mL/min/1.73 m2, among patients with at least one efficacy measurement during the open-label period. A secondary outcome was change from baseline in plasma oxalate concentration. Numerical endpoint analyses are not reported in the registry record.
The safety display reports 11 participants at risk in each of two groups, serious adverse events in 3 and 1 participants, other adverse events in 7 and 8 participants, and 0 deaths in either group. These groups reflect earlier study assignments and are not a randomized comparison within the extension.