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 Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis (NCT00598273), a randomized phase 3 study. The primary outcome is Mean Change in Hemoglobin Between Baseline and the Evaluation Period.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00598273 |
| Phase | Phase 3 |
| Condition | Chronic Renal Failure, Chronic Kidney Disease, Anemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 490 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Affymax |
| Results posted | Yes |
2. Clinical Question
Population
Participants had chronic renal failure and anemia, were not on dialysis, and were not receiving erythropoiesis-stimulating agent treatment. The primary analysis population is described as randomized participants who received at least one dose of study medication.
Intervention
The trial included peginesatide at 0.025 mg/kg and peginesatide at 0.04 mg/kg. The registry record identifies these as separate treatment arms; it does not give further arm descriptions.
Comparator
Darbepoetin alfa was the active-controlled comparator. The study was randomized and open-label. The allocation ratio and the methods used to generate or conceal the randomization sequence are not reported in the registry record.
Primary question
The primary endpoint was mean change in hemoglobin between baseline and the evaluation period, measured in g/dL. The evaluation period was Weeks 25-36. Numerical estimates for the treatment arms and a primary comparison are not reported in the registry record, so the relative results cannot be described from this record.
3. Trial Design
This was a Phase 3, randomized, active-controlled, open-label, multicenter study with a parallel-group design. It evaluated peginesatide for anemia in participants with chronic renal failure who were not on dialysis and were not receiving erythropoiesis-stimulating agent treatment. The registry lists 490 participants as the enrollment.
The three listed arms were peginesatide 0.025 mg/kg, peginesatide 0.04 mg/kg, and darbepoetin alfa. The registry identifies darbepoetin alfa as the active control. It does not report an allocation ratio, the randomization sequence method, or allocation concealment. Open-label means that masking was not used; the registry specifies masking as none. Details about any separate blinding of outcome assessment are not reported in the registry record.
The primary endpoint was mean change in hemoglobin between baseline and the evaluation period, with baseline and Weeks 25-36 specified as the timeframe. The secondary outcomes listed were the proportion of participants receiving red blood cell transfusions during the correction and evaluation periods, and the proportion achieving a hemoglobin response during those periods. The registry lists 3 outcome measures and 6 analyses, but does not report the numerical results of the primary endpoint or the secondary outcomes in this record.
The study status is completed. The recorded start was 2007-10, and primary completion was 2009-03. These registry entries describe the planned comparison and timing; they do not, by themselves, establish the results or the precision of any treatment contrast.
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 | Peginesatide 0.025 mg/kg | Peginesatide 0.04 mg/kg | Darbepoetin Alfa |
|---|---|---|---|
| STARTED | 161 | 165 | 164 |
| COMPLETED | 120 | 127 | 125 |
| NOT COMPLETED | 41 | 38 | 39 |
Reasons for not completing this period:
| Reason | Peginesatide 0.025 mg/kg | Peginesatide 0.04 mg/kg | Darbepoetin Alfa |
|---|---|---|---|
| Adverse Event | 4 | 5 | 2 |
| Death | 6 | 12 | 8 |
| Lost to Follow-up | 8 | 3 | 5 |
| Physician Decision | 0 | 0 | 1 |
| Withdrawal by Subject | 12 | 10 | 10 |
| Noncompliance | 3 | 2 | 3 |
| Relocation | 0 | 2 | 4 |
| Renal transplant | 1 | 0 | 1 |
| Site elected to close | 1 | 0 | 0 |
| Started dialysis | 6 | 4 | 5 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Population: All randomized participants who received at least one dose of study medication
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 | Peginesatide 0.025 mg/kg | Peginesatide 0.04 mg/kg | Darbepoetin Alfa | Total |
|---|---|---|---|---|---|
| Participants analysed | 161 | 165 | 164 | 490 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 70 | 63 | 65 | 198 |
| Age, Categorical: >=65 years | Participants | 91 | 102 | 99 | 292 |
| Age Continuous | years | 67.1 (SD 13.51) | 67.1 (SD 12.73) | 66.4 (SD 14.25) | 66.9 (SD 13.49) |
| Sex: Female, Male: Female | Participants | 93 | 84 | 102 | 279 |
| Sex: Female, Male: Male | Participants | 68 | 81 | 62 | 211 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Hemoglobin Between Baseline and the Evaluation Period, measured over Baseline and Weeks 25-36.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | g/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was mean change in hemoglobin between baseline and the evaluation period, measured in g/dL. The baseline value was defined as the mean of three hemoglobin values: the two most recent values taken before randomization and the value obtained on the day of randomization. For each participant, the evaluation-period value was the mean of available hemoglobin measurements during Study Weeks 25 through 36.
A continuous endpoint such as mean change uses the measured amount of change rather than only classifying participants as responders or nonresponders. In general, this can retain information about the range of measured values. The group mean gives a summary of the average change, while a measure of spread, such as the standard deviation, describes variation among individual measurements. Those summaries answer different questions: an average does not show how similar or different participants’ measurements were.
Hemoglobin was the measure selected for the primary endpoint because the study concerned correction of anemia, as reflected in the trial title and stated purpose. That rationale describes the endpoint’s connection to the study question, not a finding about the treatment. The registry record does not report the arm-specific means, mean changes, standard deviations, confidence intervals, or a primary between-group estimate. Consequently, the endpoint definition is available, but the amount and precision of observed change are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the primary outcome was mean change in hemoglobin from baseline to the evaluation period, but it does not provide the numerical outcome estimates needed to interpret the treatment comparison. There are no arm-specific mean changes or reported contrasts in the record, and no confidence intervals or p-values for the primary endpoint are reported in the registry record. The direction, magnitude, and precision of the primary results therefore cannot be described from these registry entries.
The treatment structure included two peginesatide arms and an active-control arm receiving darbepoetin alfa. This design could support comparisons among the listed arms, but the record does not state which specific pairwise contrasts were prespecified or report their results. The existence of randomized groups does not substitute for the estimates themselves: randomization describes how participants were assigned, while an estimated contrast and its uncertainty describe the observed data relevant to a treatment comparison.
The endpoint used each participant’s baseline hemoglobin summary and the mean of available measurements during Weeks 25-36. Because the evaluation value is based on available measurements, the number and timing of measurements contributing to each participant’s mean may vary. The registry record does not report the amount of missing endpoint data, how missing measurements were handled, or whether sensitivity analyses assessed their possible effect. Thus the impact of incomplete measurement on the primary estimate cannot be assessed from the record.
Safety information is reported as counts of participants affected in each arm. For serious adverse events, the registry lists 77 affected participants in the peginesatide 0.025 mg/kg arm, 75 in the peginesatide 0.04 mg/kg arm, and 71 in the darbepoetin alfa arm. For other adverse events, it lists 124, 123, and 116 affected participants, respectively. These are counts; without a reported analysis or further context, they do not establish a treatment difference. Death counts are not reported in the registry record.
The registry also lists serious adverse-event terms with percentages, including acute renal failure at 13.0%, congestive cardiac failure at 9.7%, and chronic renal failure at 7.5%. The denominator and calculation details for these percentages are not reported in the registry record. They should therefore be read as listed term-specific percentages, not as directly comparable arm-specific risks.
Overall, the record supports a description of the study question, endpoint construction, treatment arms, and some safety counts. It does not support a conclusion about the size, direction, statistical significance, or clinical importance of the primary treatment comparison. Those would require results and uncertainty estimates that are not reported in the registry record.
9. Statistical Methods Explained
What does a mean-change endpoint represent?
The primary measure is continuous: hemoglobin is recorded on a numerical scale, and the endpoint summarizes change using a mean. In general, a mean describes the center of a set of measurements, but it does not describe the full distribution. Participants may have values above and below that average, and the spread of those values matters when interpreting how representative the mean is. The registry names standard deviation as the dispersion measure for the primary outcome, but does not give the observed standard deviations.
The baseline definition combines three measurements rather than relying on a single value. The evaluation-period summary uses the available hemoglobin values during Weeks 25-36. In general, averaging measurements can reduce the influence of a single unusually high or low reading, but a summary based on available observations can also differ in precision across participants if the amount of observed data varies. The registry does not report the number of available measurements per participant or the distribution of measurement completeness.
How should a treatment contrast be read?
In general, a between-group contrast compares an outcome summary between randomized groups. For a mean-change endpoint, it would describe how the average change in one group compares with the average change in another. A contrast is not the same as either group’s mean change on its own. Interpretation also depends on its uncertainty: a confidence interval gives a range of values compatible with the data and analysis under the method’s assumptions. A narrow interval indicates greater precision than a wide interval, though precision alone does not determine clinical importance.
The registry record does not report the primary arm summaries, a contrast, a confidence interval, or a p-value. It therefore does not permit a numerical interpretation of any primary comparison. The record also does not state which comparisons among the peginesatide doses and darbepoetin alfa formed the primary statistical test. No inference about statistical significance should be made from the design description or the safety counts.
What does randomization contribute?
In general, random assignment is intended to make treatment groups comparable at the start of a trial, on average, with respect to measured and unmeasured factors. It does not guarantee exact balance in any particular trial, and it does not eliminate the need to report how outcomes were analyzed. The registry identifies the study as randomized, but the randomization sequence method and allocation concealment are not reported in the registry record. Baseline group characteristics and any adjustment strategy are also not reported.
The open-label design means masking was not used. In general, knowledge of assigned treatment can affect behavior, co-interventions, reporting, or assessment, depending on the outcome and study procedures. Hemoglobin is a laboratory measurement, but the registry does not describe procedures for blinded laboratory assessment or blinded outcome review. The implications of open-label conduct therefore cannot be fully characterized from this record alone.
What is over-dispersion, and why might it matter?
General statistical note: over-dispersion occurs when observed variability is greater than a model assumes. It can make standard errors too small if the analysis does not account for the extra variation, leading to confidence intervals that are too narrow and p-values that are too small. This issue is most relevant when a model’s assumed distribution does not capture the observed spread. The primary endpoint is a continuous mean, and the registry names standard deviation as its dispersion measure; it does not report model details or any assessment of over-dispersion. No claim that over-dispersion was present or addressed can be made from the registry record.
What do the planning assumptions mean?
The record’s sample-size assumptions describe a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not a substitute for results. The registry record does not report the trial’s own sample-size justification, the effect assumed when the trial was designed, or whether the trial was planned around the same assumptions as the illustration. The numerical planning outputs are not reported in the registry record.
General note: a planning calculation estimates the number of participants per arm that would be needed under its specified assumptions. It does not tell readers the probability that a completed trial’s result is correct, and it does not show whether the actual study detected an effect. Its meaning depends on the assumed outcome variability, target effect, significance level, allocation, and analysis model. If those assumptions differ from the completed study, the illustration may not describe the study’s actual design or operating characteristics.
What can the adverse-event counts establish?
The registry reports affected-participant counts for serious adverse events and other adverse events, organized by treatment arm. In general, a count records how many participants met the stated event definition, while a risk estimate requires an interpretable denominator and a defined observation period. Counts alone do not account for differences in time at risk, event recurrence, or the severity and timing of events. The record gives numbers at risk for the adverse-event summaries, but it does not provide an event-analysis method or report comparative estimates with uncertainty. The term-specific percentages are not accompanied by denominator details in this record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and 6 analyses, as well as a primary endpoint and secondary outcomes concerning red blood cell transfusion and hemoglobin response. Multiple outcomes, treatment arms, time periods, and possible pairwise comparisons can create a multiplicity issue: when many statistical tests are considered, the chance of at least one apparently notable result can increase. In general, study plans can address this through prespecified outcome hierarchies, adjusted significance thresholds, or other procedures. The multiplicity strategy is not reported in the registry record.
The record does not report whether a single primary contrast was designated among the two peginesatide doses and darbepoetin alfa, whether secondary outcomes were confirmatory or exploratory, or whether any adjustment was made for multiple testing. It also does not provide the numerical test results. Accordingly, no claim about multiplicity-adjusted or unadjusted statistical significance can be made.
The primary analysis population is defined as all randomized participants who received at least one dose of study medication. This definition does not include randomized participants who received no study medication. The registry does not report how many participants were excluded under this definition or provide details about other analysis populations, such as a per-protocol population.
The primary endpoint uses available hemoglobin measurements during Weeks 25-36. The registry does not report missing-data counts, reasons for missing measurements, imputation methods, or sensitivity analyses. It also does not report how withdrawals or incomplete follow-up were handled. These omissions limit assessment of whether observed data could differ systematically from unobserved data and whether the analysis is robust to that possibility. The detailed statistical analysis plan is not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Peginesatide 0.025 mg/kg | 77 | 161 | 47.8% |
| Peginesatide 0.04 mg/kg | 75 | 165 | 45.5% |
| Darbepoetin Alfa | 71 | 164 | 43.3% |
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 |
|---|---|
| Peginesatide 0.025 mg/kg | 124 of 161 |
| Peginesatide 0.04 mg/kg | 123 of 165 |
| Darbepoetin Alfa | 116 of 164 |
Most frequent serious adverse event terms
| Event term | Organ system | Peginesatide 0.025 mg/kg | Peginesatide 0.04 mg/kg | Darbepoetin Alfa |
|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | 15 of 161 | 16 of 165 | 14 of 164 |
| Renal failure acute | Renal and urinary disorders | 21 of 161 | 13 of 165 | 9 of 164 |
| Pneumonia | Infections and infestations | 10 of 161 | 8 of 165 | 9 of 164 |
| Renal failure chronic | Renal and urinary disorders | 12 of 161 | 3 of 165 | 8 of 164 |
| Urinary tract infection | Infections and infestations | 5 of 161 | 9 of 165 | 7 of 164 |
| Cellulitis | Infections and infestations | 6 of 161 | 5 of 165 | 3 of 164 |
| Atrial fibrillation | Cardiac disorders | 3 of 161 | 7 of 165 | 3 of 164 |
| Azotaemia | Renal and urinary disorders | 4 of 161 | 3 of 165 | 6 of 164 |
| Renal failure | Renal and urinary disorders | 5 of 161 | 4 of 165 | 4 of 164 |
| Hypertension | Vascular disorders | 3 of 161 | 5 of 165 | 5 of 164 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Peginesatide 0.025 mg/kg | Peginesatide 0.04 mg/kg | Darbepoetin Alfa |
|---|---|---|---|---|
| Hyperkalaemia | Metabolism and nutrition disorders | 32 of 161 | 22 of 165 | 27 of 164 |
| Oedema peripheral | General disorders | 31 of 161 | 27 of 165 | 18 of 164 |
| Urinary tract infection | Infections and infestations | 22 of 161 | 24 of 165 | 24 of 164 |
| Nausea | Gastrointestinal disorders | 27 of 161 | 15 of 165 | 22 of 164 |
| Diarrhoea | Gastrointestinal disorders | 22 of 161 | 17 of 165 | 22 of 164 |
| Dizziness | Nervous system disorders | 14 of 161 | 19 of 165 | 24 of 164 |
| Hypertension | Vascular disorders | 24 of 161 | 16 of 165 | 17 of 164 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 19 of 161 | 19 of 165 | 14 of 164 |
| Constipation | Gastrointestinal disorders | 20 of 161 | 15 of 165 | 16 of 164 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 16 of 161 | 17 of 165 | 17 of 164 |
Serious events with the highest arm-level rate: renal failure acute (13.0%), cardiac failure congestive (9.7%), renal failure chronic (7.5%), pneumonia (6.2%), urinary tract infection (5.5%).
The registry reports serious adverse-event counts of 77 for peginesatide 0.025 mg/kg, 75 for peginesatide 0.04 mg/kg, and 71 for darbepoetin alfa. For other adverse events, the corresponding counts are 124, 123, and 116. The record also lists the numbers at risk for these summaries: 161, 165, and 164, respectively. These are descriptive counts and denominators, not adjusted comparisons.
Among the listed serious adverse-event terms, the registry reports acute renal failure at 13.0%, congestive cardiac failure at 9.7%, chronic renal failure at 7.5%, pneumonia at 6.2%, urinary tract infection at 5.5%, and atrial fibrillation at 4.2%. The record does not state the denominator or calculation method for these percentages, or provide arm-specific percentages for these terms. Their values should not be treated as comparative risks across treatment groups.
Death counts are not reported in the registry record. The record also does not provide event timing, recurrence, severity grades, exposure-adjusted rates, or statistical comparisons. The reported counts therefore describe the posted safety summaries but do not, on their own, establish whether one treatment arm had greater or lesser safety risk.
12. What the Result Does, and Does Not, Mean
This trial’s registry record identifies a randomized, open-label comparison of two peginesatide dose arms with darbepoetin alfa in participants with chronic renal failure who were not on dialysis and were not receiving erythropoiesis-stimulating agent treatment. It defines a primary hemoglobin outcome based on baseline and measurements during Weeks 25-36. These details clarify the question the study was designed to address.
The record does not report numerical primary-outcome results. Without arm-specific estimates, a between-group contrast, and a measure of uncertainty, it is not possible to state how the observed hemoglobin changes compared, how precise any comparison was, or whether it was statistically distinguishable from no difference. The endpoint definition and trial design are not evidence of a result by themselves.
The safety summaries provide counts of participants affected by serious and other adverse events, plus a list of serious adverse-event terms and percentages. These summaries do not include the methodological detail needed to interpret the term percentages as arm-specific comparative risks. Counts also do not describe event timing or recurrence. They should be understood as descriptive registry information, not as a complete comparative safety analysis.
The record likewise does not establish how missing outcome data were handled, what multiplicity procedures were used, or which statistical contrasts were prespecified. Those details can influence interpretation of estimates and tests. A full understanding of the trial’s findings would require reported outcome estimates, their uncertainty, and the analysis details; these are not reported in the registry record.
Accordingly, the record supports statements about the trial’s population, design, endpoint definition, and posted safety counts. It does not support a conclusion that peginesatide or darbepoetin alfa performed better or worse on the primary outcome, nor does it support medical advice. The absence of reported estimates is a limitation of what can be interpreted from this registry record, not evidence for a particular treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically notable for asking a continuous-outcome question in a randomized, active-controlled design. Its primary endpoint was not simply whether participants crossed a response threshold; it was mean change in hemoglobin, defined using a baseline summary and a later evaluation-period mean. Such a definition makes the timing and completeness of repeated measurements important to understanding the analysis.
The three-arm design included two peginesatide doses and an active comparator. That creates more than one possible treatment contrast, while the registry also lists secondary outcomes related to transfusion and hemoglobin response. In general, a collection of outcomes and comparisons makes prespecification and multiplicity handling important. The registry record identifies 3 outcome measures and 6 analyses, but does not report the statistical plan or multiplicity strategy.
The stated analysis population is also relevant: randomized participants who received at least one dose of study medication. This is a defined population, but the record does not report how many participants were analyzed or how missing endpoint data were handled. Readers therefore cannot assess the possible effects of exclusions or incomplete measurements from this record alone.
Finally, the reported safety summaries illustrate why raw counts and comparative estimates serve different purposes. Counts describe the number affected, while interpretation of relative safety requires clear denominators, time-at-risk information, and appropriate uncertainty. The term-specific percentages lack denominator details in the registry record. The main statistical lesson is that a clear endpoint and randomized design are not enough to interpret efficacy or safety without estimates, precision measures, and transparent analysis details.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record gives the primary endpoint definition but not its numerical results. Arm-specific mean changes, standard deviations, between-group estimates, confidence intervals, and p-values are not reported in the registry record. As a result, the direction, size, and precision of the primary comparison cannot be assessed from this information.
The record does not report the randomization sequence method, allocation concealment, allocation ratio, baseline characteristics, or details of outcome assessment. It identifies the study as open-label, but does not describe whether laboratory measurements or outcome assessments were independently masked. These omissions limit evaluation of design and conduct details beyond the broad trial classification.
The endpoint definition uses available measurements during Weeks 25-36, but missing-data amounts, reasons for missingness, imputation, and sensitivity analyses are not reported. The record also does not describe adherence, treatment discontinuation, protocol deviations, or the handling of participants who did not contribute the expected measurements. These details matter when interpreting an analysis based on a defined analysis population and available observations.
Although the record lists secondary outcomes, it does not report their numerical findings or how analyses across outcomes and treatment comparisons were prioritized or adjusted. The statistical analysis plan and the trial’s sample-size justification are not reported in the registry record. The planning assumptions described for an illustration should not be mistaken for the trial’s original design rationale or for observed power.
Safety limitations include the absence of death counts, event timing, recurrence information, exposure-adjusted rates, and comparative uncertainty estimates. The denominator and calculation method for the listed serious adverse-event term percentages are not reported in the registry record. The counts and terms therefore offer only a partial descriptive view of safety and do not support a full comparative assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis — NCT00598273.
- Registry record last updated 2013-02-12; status last verified 2013-02.
- Results first posted 2012-07-30.
- 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 NCT00598273, a completed Phase 3 randomized, active-controlled, open-label, multicenter, parallel-group study sponsored by Affymax. It lists an enrollment of 490 and concerns anemia in participants with chronic renal failure who were not on dialysis or erythropoiesis-stimulating agent treatment. The recorded start was 2007-10, and primary completion was 2009-03.
The treatment arms were peginesatide 0.025 mg/kg, peginesatide 0.04 mg/kg, and darbepoetin alfa. The primary endpoint was mean change in hemoglobin between baseline and Weeks 25-36. Secondary outcomes concerned red blood cell transfusions and hemoglobin response. The record includes adverse-event counts and serious adverse-event terms, but numerical primary-outcome estimates, detailed statistical methods, and several safety-analysis details are not reported in the registry record.