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 Mechanisms of EPO-induced Hypertension (NCT03810911), a randomized phase 2 study. The primary outcome is Change in Diastolic Blood Pressure in EPO Treated Patients Compared to Delayed Start Controls.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03810911 |
| Phase | Phase 2 |
| Condition | Chronic Kidney Disease, Blood Pressure, Anemia |
| Allocation | Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | 2 |
| Lead sponsor | VA Office of Research and Development |
| Results posted | Yes |
2. Clinical Question
The study asks whether starting erythropoietin therapy immediately, compared with delaying treatment, is associated with a change in diastolic blood pressure over the first 12 weeks. The investigators’ stated hypothesis is that erythropoietin treatment will raise diastolic blood pressure in anemic patients with chronic kidney disease. They also propose that the magnitude of change may relate to endothelial function and to forearm blood-flow responses to breathing oxygen, including changes in those measures by 4 weeks.
Population
People with chronic kidney disease and anemia were the intended population. The registry record reports enrollment of 27 participants. Further eligibility details are not reported in the registry record.
Intervention
Darbepoetin, an erythropoietin therapy, was given immediately after randomization to the Early Start group. The study also describes blood-pressure monitoring, blood draws, urine collection, and forearm blood-flow tests.
Comparator
The Delayed Start group did not begin study treatment during the initial 12-week comparison period; treatment was scheduled to begin 12 weeks after randomization. This makes the initial comparison one of immediate versus delayed treatment.
Primary question
How did mean diastolic blood pressure change from baseline to 12 weeks in the Early Start group compared with the Delayed Start group? The registry reports each group’s mean change and confidence interval, but not a direct estimate or test of the between-group difference.
3. Trial Design
This was a Phase 2 randomized trial with a sequential model and no masking. Participants were assigned to an Early Start group, which received study drug at randomization, or a Delayed Start group, which began study drugs 12 weeks after randomization. The initial 12 weeks therefore provide the primary comparison between participants assigned to immediate treatment and participants assigned to delayed treatment.
The primary endpoint covers baseline to 12 weeks. The registry reports results for 11 participants in Early Start and 16 in Delayed Start, for a total enrollment of 27. The brief summary says the study hoped to accrue 160 subjects. The reason enrollment stopped short of that target is not reported in the registry record. The study status is terminated; the reason for termination is not reported in the registry record.
After the initial comparison period, the delayed group’s outcomes were also considered across periods when participants were not on EPO and when they were on EPO. This delayed-start structure can allow a within-group comparison across treatment periods, but it does not make those periods equivalent to a separately randomized comparison: time and treatment status change together. The registry lists secondary outcomes concerning systolic pressure, worsening hypertension status, endothelial function, and urine albumin-to-creatinine ratio. Results for all of those outcomes are not reported in the registry record.
The registry record does not report the randomization procedure, allocation concealment, a formal sample-size justification, or details of the analysis plan. No masking was used, so treatment assignment was not concealed from participants and study personnel. Whether outcome assessors were masked is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: 65 individuals (41%) consented, of which, 27 (42%) were enrolled in the trial and underwent randomization stratified by the level of albuminuria (KDIGO stage A1, A2, or A3). 16 were assigned to waitlisted and 11 to immediate start group. In each of the two groups, two patients did not complete the study. The most common reason for randomization failure was either Hgb out of range (39%) or ambulatory BP out of range (39%). The trial was stopped because of inability to reach target sample size.
Overall Study
| Stage | Early Start | Delayed Start |
|---|---|---|
| STARTED | 11 | 16 |
| COMPLETED | 9 | 14 |
| NOT COMPLETED | 2 | 2 |
Reasons for not completing this period:
| Reason | Early Start | Delayed Start |
|---|---|---|
| Death | 1 | 1 |
| Withdrawal by Subject | 1 | 1 |
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: Randomization was stratified by the level of albuminuria in a 1:1 ratio to either early or delayed treatment with ESA. A random permuted block design was used to avoid imbalance in assignment to the study drugs over time. After confirming eligibility, the principal investigator used a computer program to reveal the group assignment.
| Characteristic | Unit | Early Start | Delayed Start | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 16 | 27 | |
| Sex: Female, Male: Female | Participants | 1 | 4 | 5 |
| Sex: Female, Male: Male | Participants | 10 | 12 | 22 |
| Race/Ethnicity, Customized: Self stated race – White | Participants | 10 | 9 | 19 |
| Race/Ethnicity, Customized: Self stated race – Black | Participants | 1 | 7 | 8 |
| Weight -- kg (SD) | kg | 99.3 (SD 19.7) | 88.5 (SD 24.5) | 92.9 (SD 22.9) |
| Age, Customized: Age - years (SD) | Years | 74.6 (SD 6) | 75.1 (SD 9.3) | 74.9 (SD 8) |
| Medical History: Diabetes -- n (%) | Participants | 8 | 9 | 17 |
| Medical History: Myocardial infarction -- n (%) | Participants | 2 | 4 | 6 |
| Medical History: Stroke -- n (%) | Participants | 1 | 1 | 2 |
| Medical History: Coronary revascularization -- n (%) | Participants | 4 | 6 | 10 |
| Medical History: Heart failure hospitalization -- n (%) | Participants | 5 | 5 | 10 |
| Hemoglobin -- g/dL (SD) | g/dL | 9.4 (SD 0.6) | 9.5 (SD 0.7) | 9.4 (SD 0.6) |
| Serum ferritin -- ng/mL (25th-75th percentile) | ng/mL | 110 (11 to 194) | 91 (40 to 434) | 95 (38 to 353) |
| Transferrin saturation -- percent (SD) | % | 21 (SD 9.8) | 24.2 (SD 15.5) | 23 (SD 13.3) |
| Baseline eGFR -- mL/min/1.73m^2 (SD) | mL/min/1.73m^2 | 38.6 (SD 11.7) | 36 (SD 13.9) | 37.1 (SD 12.9) |
| Glomerular filtration rate (GFR) category (G1-G5): G2 -- n (%) | Participants | 0 | 1 | 1 |
| Glomerular filtration rate (GFR) category (G1-G5): G3a -- n (%) | Participants | 5 | 3 | 8 |
| Glomerular filtration rate (GFR) category (G1-G5): G3b -- n (%) | Participants | 4 | 6 | 10 |
| Glomerular filtration rate (GFR) category (G1-G5): G4 -- n (%) | Participants | 2 | 6 | 8 |
| Albuminuria category (A1-A3): A1 -- n (%) | Participants | 4 | 5 | 9 |
| Albuminuria category (A1-A3): A2 -- n (%) | Participants | 5 | 8 | 13 |
| Albuminuria category (A1-A3): A3 -- n (%) | Participants | 2 | 3 | 5 |
| Baseline UACR -- mg/g creatinine median (25th-75th) | mg/g | 39 (15 to 60) | 79 (16 to 191) | 56 (15 to 183) |
| Baseline clinic blood pressure: Clinic systolic blood pressure -- mmHg (SD) | mmHg | 125.1 (SD 22.1) | 123.2 (SD 15.8) | 124.4 (SD 19.5) |
| Baseline clinic blood pressure: Clinic diastolic blood pressure -- mmHg (SD) | mmHg | 58.5 (SD 12.1) | 55.4 (SD 10.6) | 57.2 (SD 11.4) |
| Antihypertensive drugs -- n (SD) | Drugs | 3.5 (SD 1.2) | 3 (SD 1.2) | 3.2 (SD 1.2) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Diastolic Blood Pressure in EPO Treated Patients Compared to Delayed Start Controls, measured over Baseline to 12 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the mean change in diastolic blood pressure, measured in mmHg, from baseline to 12 weeks. Diastolic pressure is the lower of the two usual blood-pressure readings and reflects pressure during the heart’s relaxation phase. The endpoint compares the change in the Early Start group with the change in the Delayed Start group over the same period.
Using change from baseline focuses the comparison on how pressure shifted during follow-up rather than on the groups’ measurements at a single time point. A delayed-start group provides a control for changes that may occur over the same period without immediate study treatment. The endpoint is therefore intended to capture a treatment-period contrast, not simply whether participants had high or low pressure at baseline.
The registry reports a mean change of 1.4 mmHg for Early Start, with a 95% confidence interval from -1.8 to 4.6, and -0.5 mmHg for Delayed Start, with a 95% confidence interval from -4.7 to 3.8. It does not report a direct estimate of the difference between these group means or a corresponding statistical test. The endpoint results consequently describe the observed changes in each group, but do not by themselves establish the precision of the between-group contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
For the primary endpoint, the Early Start group had a reported mean change in diastolic blood pressure of 1.4 mmHg from baseline to 12 weeks. Its 95% confidence interval extends from -1.8 to 4.6. The Delayed Start group had a mean change of -0.5 mmHg, with a 95% confidence interval from -4.7 to 3.8. Both intervals include zero, so the posted group-specific estimates are compatible with no mean change in either group as well as with changes in either direction.
These are separate group estimates, not a reported estimate of the treatment contrast. The registry record does not report the between-group difference, its confidence interval, or a primary-outcome p-value. A reader should not treat the apparent separation between the two group means as a tested treatment effect. Nor can the two separate confidence intervals be used as a substitute for a confidence interval for the difference; the precision of a contrast depends on the comparison’s analysis and data.
The posted sample sizes are small: 11 participants in Early Start and 16 in Delayed Start. With few observations, estimates can be imprecise, and a confidence interval may remain broad even when the point estimate appears to favor one direction. The primary intervals span values on both sides of zero. Thus, the registry results do not pin down whether the mean change under immediate treatment differed from the mean change under delayed treatment, or how large any such difference might be.
The study was terminated after enrolling 27 participants, while its brief summary says it hoped to accrue 160 subjects. The reason for termination is not reported in the registry record. The enrollment shortfall is relevant to precision and to how completely planned outcomes may be represented, but it does not establish why the study stopped or what its results would have been with more participants.
Overall, the posted primary results describe modestly different point estimates for the two groups but leave substantial uncertainty about the comparative effect. They should be read as descriptive registry results rather than as a conclusive test of the study hypothesis. The registry record does not report a sponsor-conducted primary comparison that would allow a direct inferential conclusion.
9. Statistical Methods Explained
The primary outcome is continuous: each participant’s blood pressure is measured on a numeric scale, and the registry reports a mean change for each group. The mean provides a summary of the group’s average change, while the confidence interval communicates uncertainty around that estimate. A 95% confidence interval is a range generated by a statistical procedure that, under its assumptions and repeated use, would contain the target quantity in 95% of such intervals. It is not a statement that there is a 95% probability that this particular fixed quantity lies in the reported range.
What do the primary confidence intervals describe?
The posted intervals describe the mean change in each arm separately. They do not describe the difference between arms. For a randomized comparison, the treatment question concerns the difference in outcomes between assigned groups, with an estimate and uncertainty calculated for that contrast. The registry record gives no such primary contrast, no primary-outcome p-value, and no reported analysis method for it. The group-specific intervals therefore do not answer the comparative question on their own. The fact that an interval includes zero is not equivalent to a formal test of the difference between groups.
How should the secondary binary outcomes be read?
For the secondary outcomes about worsening hypertension, the results are counts of participants meeting the outcome in each group or period. The registry also reports unadjusted risk differences and confidence intervals for two comparisons. A risk difference expresses the difference between two proportions; its interval represents uncertainty in that contrast. In the immediate-versus-delayed comparison, the reported risk difference is 0.165, with a 95% confidence interval from -0.194 to 0.523 and an unadjusted p-value of 0.384. In the delayed group’s comparison across periods, the reported risk difference is 0.0, with a 95% confidence interval from -0.344 to 0.344 and an unadjusted p-value of 1.0. These are unadjusted secondary comparisons, not evidence that the primary outcome has the same result.
A p-value summarizes how incompatible the observed data are with a specified null hypothesis under the assumptions of the test. It does not measure the probability that a hypothesis is true, the size or importance of an effect, or the probability that a result will replicate. Confidence intervals add information about the range of effects compatible with the data under the analysis assumptions. Here, the secondary intervals include zero and are wide, so they leave considerable uncertainty about the corresponding differences.
What do the sample-size illustrations mean?
The registry includes a planning illustration based on the observed effect for the first reported binary secondary comparison. It gives participants per arm for 80% and 90% power under a two-sided significance level of 0.05, equal allocation, and a normal approximation. It considers planning for 100%, 75%, and 50% of the observed effect. These are hypothetical design calculations, not the number enrolled in this trial and not observed power. For example, the illustration lists 132 participants per arm for 80% power when planning for 100% of the observed effect, 228 when planning for 75%, and 497 when planning for 50%. The corresponding figures for 90% power are 176, 305, and 665 participants per arm.
Because the illustration uses an observed effect from a small study, it should not be treated as a reliable estimate of the effect a future study must detect. Planning around a smaller fraction of an observed effect requires a larger sample in the illustration. The registry record does not report that these assumptions were used to design the trial. A formal sample-size justification, including the effect size chosen for the original design, is not reported in the registry record.
Why can small studies produce uncertain estimates?
General statistical explanation: estimates based on fewer participants tend to be more sensitive to the particular observations included, and their uncertainty is often greater than estimates based on larger samples. This does not mean a small study’s observed estimate is necessarily wrong; it means the data may support a broad range of plausible effects. General statistical explanation: over-dispersion occurs when outcome variability is greater than a model assumes. If present and unaccounted for, it can make standard errors and confidence intervals too optimistic. The registry record does not report an over-dispersion assessment or enough model detail to determine whether that issue applies.
The registry reports no analysis count for the posted results, and reported analyses are not listed for the two secondary outcomes with comparisons. It does not report whether analyses followed intention-to-treat principles, how missing measurements were handled, or whether adjustment for baseline measurements or other covariates was used. Those omissions limit assessment of the exact statistical procedures and of how robust the estimates are to analytic choices.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, including the primary endpoint and secondary outcomes, but reports results for only some of the listed outcomes. Results for the unreported outcomes, including the stated endothelial-function and urine albumin-to-creatinine measures, are not reported in the registry record. The record lists no reported analyses for the two secondary outcomes with posted comparisons. It does not explain whether the remaining outcomes were not measured, were not analyzed, or were analyzed but not posted.
Multiplicity matters when a study considers several outcomes or comparisons. General statistical explanation: if many hypotheses are tested, the likelihood of obtaining at least one small p-value by chance can rise unless the analysis plan accounts for the number or structure of tests. The two posted secondary p-values are unadjusted. Whether the investigators used an adjustment or a testing hierarchy for other outcomes is not reported in the registry record. A prespecified statistical analysis plan, interim analyses, and any rules for stopping the trial are also not reported in the registry record.
Details about missing outcome data are not reported in the registry record. It does not state how many participants contributed measurements at each follow-up, whether participants withdrew, why any measurements might be missing, or how missing data were handled. The primary arm counts sum to the reported enrollment, but that alone does not establish that every enrolled participant completed the endpoint or that all randomized participants were included in the analysis.
The analysis population is not described: the registry record does not say whether results use an intention-to-treat population, a per-protocol population, or another definition. It also does not report whether the main comparison adjusted for baseline blood pressure or other variables. The reason for trial termination is not reported in the registry record. These gaps make it difficult to assess how outcome selection, missingness, or analysis-population decisions may have influenced the posted results.
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 |
|---|---|---|---|
| Darbepoetin | 8 | 27 | 29.6% |
| No Darbepoetin | 5 | 16 | 31.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Darbepoetin | 2 of 27 |
| No Darbepoetin | 0 of 16 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Darbepoetin | 6 of 27 |
| No Darbepoetin | 7 of 16 |
Most frequent serious adverse event terms
| Event term | Organ system | Darbepoetin | No Darbepoetin |
|---|---|---|---|
| Congestive heart failure | Cardiac disorders | 3 of 27 | 0 of 16 |
| Arrhythmia | Cardiac disorders | 0 of 27 | 2 of 16 |
| Hypertensive crisis | Cardiac disorders | 2 of 27 | 0 of 16 |
| Peripheral vascular disorder | Cardiac disorders | 1 of 27 | 1 of 16 |
| Falls | General disorders | 0 of 27 | 1 of 16 |
| Seizures | Nervous system disorders | 0 of 27 | 1 of 16 |
| Venous thromboembolism | Blood and lymphatic system disorders | 1 of 27 | 0 of 16 |
| Empyema | Infections and infestations | 1 of 27 | 0 of 16 |
| Abnormal renal labs | Renal and urinary disorders | 1 of 27 | 0 of 16 |
| GI bleed | Gastrointestinal disorders | 1 of 27 | 0 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Darbepoetin | No Darbepoetin |
|---|---|---|---|
| Skin irritation or rash | Skin and subcutaneous tissue disorders | 1 of 27 | 2 of 16 |
| Constipation | Gastrointestinal disorders | 2 of 27 | 1 of 16 |
| Falls | General disorders | 0 of 27 | 1 of 16 |
| Diarrhea | Gastrointestinal disorders | 0 of 27 | 1 of 16 |
| Cellulitis | Infections and infestations | 0 of 27 | 1 of 16 |
| Musculoskeletal injury | Musculoskeletal and connective tissue disorders | 1 of 27 | 0 of 16 |
| Hypoglycemia | General disorders | 1 of 27 | 0 of 16 |
| Hyperkalemia | Renal and urinary disorders | 0 of 27 | 1 of 16 |
| Delerium | General disorders | 0 of 27 | 1 of 16 |
| Urinary tract infection | Infections and infestations | 1 of 27 | 0 of 16 |
Serious events with the highest arm-level rate: arrhythmia (12.5%), congestive heart failure (11.1%), hypertensive crisis (7.4%), falls (6.2%), peripheral vascular disorder (6.2%).
The registry reports serious adverse events for the Darbepoetin group and the No Darbepoetin group. The at-risk counts are 27 and 16, respectively. The record lists 8 participants with serious adverse events in the Darbepoetin group and 5 in the No Darbepoetin group. It also lists other adverse events in 6 of 27 and 7 of 16 participants, respectively. Deaths are reported for 2 participants in the Darbepoetin group and none in the No Darbepoetin group.
These are descriptive counts. The registry record does not provide enough detail to determine from these figures whether events were caused by treatment, when they occurred, how severe they were, or whether participants experienced more than one event. The groups also differ in their reported at-risk counts, so the counts should not be read as a direct comparison of risk without an appropriate analysis. The record does not report a statistical comparison of adverse-event rates.
The listed serious-event terms include Arrhythmia (12.5%), Congestive heart failure (11.1%), Hypertensive crisis (7.4%), Falls (6.2%), Peripheral vascular disorder (6.2%), and Seizures (6.2%). The registry does not give enough context alongside these percentages to infer a treatment-specific rate or causal relationship. These safety figures describe what was posted; they do not establish whether darbepoetin caused any event or whether the groups’ safety profiles differed.
12. What the Result Does, and Does Not, Mean
The primary results show the mean diastolic blood-pressure change reported for each randomized group over baseline to 12 weeks. The Early Start estimate is 1.4 mmHg, with a 95% confidence interval from -1.8 to 4.6; the Delayed Start estimate is -0.5 mmHg, with a 95% confidence interval from -4.7 to 3.8. The estimates are imprecise, and the registry does not report a direct between-group estimate or test. The results therefore do not establish the size or direction of a comparative treatment effect.
These findings do not show that treatment works or does not work. They do not establish that EPO caused a change in blood pressure, and they do not prove that the groups were equivalent. A lack of a reported primary comparison is not evidence of no difference. The group-specific intervals are compatible with changes in either direction, and a comparison requires its own estimate and uncertainty.
The secondary hypertension-status findings offer additional but limited context. They are based on small groups and unadjusted comparisons, with uncertainty that includes no difference. They should not be used to replace the primary endpoint or to make a definitive claim about the study hypothesis. The registry does not post enough results to assess all listed secondary questions, including the proposed relationships with endothelial function and forearm blood flow.
The study’s enrollment of 27 is below the 160 subjects the brief summary says it hoped to accrue. The reason for termination and the consequences for completion of planned follow-up are not reported in the registry record. Sample-size illustrations based on observed effects are hypothetical planning aids, not evidence that the study had a particular probability of detecting an effect.
In practical terms, the posted data are best understood as a limited and uncertain record of group-level changes, accompanied by incomplete secondary and analysis details. They do not support a confident quantitative conclusion about the comparative effect of immediate versus delayed darbepoetin on diastolic blood pressure.
13. Why This Trial Matters Statistically
This trial illustrates why the form of a reported estimate matters. The primary question is comparative, but the registry gives separate mean changes for each group rather than the estimated difference between groups. Even when the arm-specific estimates are easy to read, they do not directly answer whether the groups changed differently. A direct contrast with its confidence interval would communicate both the direction and precision of the primary comparison.
It also illustrates how uncertainty can be consequential in small trials. The primary confidence intervals are broad and include values on both sides of zero, while the reported enrollment is 27. The posted estimates should not be treated as precise merely because numerical values are available. A point estimate is only one part of the result; its uncertainty and the design of the comparison matter just as much.
The secondary binary comparisons show another important distinction: counts, risk differences, confidence intervals, and p-values answer related but different questions. Unadjusted results across multiple outcomes are exploratory, especially when the registry does not report a multiplicity plan or a hierarchy of tests. Sample-size illustrations based on observed effects can help show how planning assumptions affect required enrollment, but they are not observed power and do not substitute for the original design justification.
Finally, the record has gaps that affect interpretation: several listed outcomes have no posted results, and details about missing data, analysis populations, and the reason for termination are not reported. Statistical interpretation depends not only on the values shown but also on how those values were generated and which planned analyses were completed. This trial is a useful example of why complete reporting of estimates, uncertainty, analysis methods, and outcome status is important for clinical research readers.
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 the available record. First, enrollment was 27, while the brief summary says the study hoped to accrue 160 subjects. The reason for termination is not reported in the registry record, so it is not possible to determine why recruitment ended or whether the planned follow-up was completed. The relatively small reported groups also leave the primary estimates imprecise.
Second, the registry does not report a direct primary between-group estimate, confidence interval, or p-value. The group-specific mean changes cannot substitute for that contrast. It also does not report enough detail about the statistical analysis to determine whether baseline adjustment, a repeated-measures approach, or another method was used.
Third, the study was unmasked. The registry record does not describe whether outcome assessment or data analysis was masked, nor does it report allocation concealment. These missing details limit assessment of potential influences on measurement or conduct, although the record alone does not establish that any such influence occurred.
Fourth, only some secondary results are posted, and the posted secondary comparisons are unadjusted. The record does not report a multiplicity plan, the status of every listed outcome, the handling of missing data, or the analysis populations. This makes it difficult to judge whether the available results represent the full set of planned analyses.
Finally, the delayed-start design means later comparisons in the delayed group contrast periods that differ in both time and treatment status. Such comparisons may be informative, but they are not equivalent to a fresh randomized comparison at each period. The registry does not report enough methodological detail to assess how that feature was handled analytically.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Mechanisms of EPO-induced Hypertension — NCT03810911.
- Registry record last updated 2025-12-15; status last verified 2025-11.
- Results first posted 2025-12-15.
- 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 NCT03810911, “Mechanisms of EPO-induced Hypertension,” a Phase 2 randomized, open-label study with a sequential model. The sponsor is the VA Office of Research and Development. The recorded start date is 2021-01-04, and the primary completion date is 2024-12-31. The study status is terminated.
The intervention was darbepoetin, with an Early Start group and a Delayed Start group. Enrollment was 27. The primary endpoint was change in mean diastolic blood pressure from baseline to 12 weeks, reported separately by group. The record also lists secondary blood-pressure, hypertension-status, endothelial-function, and urine-measure outcomes, but results for several listed outcomes are not reported in the registry record.
The registry reports serious and other adverse-event counts and deaths by treatment group. It does not report a direct primary between-group analysis, the reason for termination, or key details about missing data and analysis populations. These omissions, together with the limited enrollment, constrain interpretation of the posted findings.