Trial · NCT00597753
Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
NCT00597753, Phase 3, Completed, Affymax; results first posted 2012-07-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis. Trials, record NCT00597753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis
- NCT number
- NCT00597753
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 803 participants, actual
- Lead sponsor
- Affymax
- Conditions
- Chronic Renal Failure, Chronic Kidney Disease, Anemia
- Interventions
- peginesatide, Epoetin Alfa
- First posted
- 2008-01-18
- Last updated
- 2013-02-12
- Results first posted
- 2012-07-30
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Baseline and Weeks 29-36 | The baseline hemoglobin value is defined as the mean of five hemoglobin values: the four most recent hemoglobin values taken prior to the day of randomization and the value obtained on the day of randomization. The mean hemoglobin during the Evaluation Period for each participant is calculated as the mean of the available hemoglobin values during study Weeks 29 through 36. |
| Secondary | Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Weeks 0 to 36 | |
| Secondary | Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) | Weeks 29 to 36 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Baseline and Weeks 29-36 | Full Analysis Population: All randomized participants who received at least one dose of study medication | g/dL | MEAN |
| SECONDARY | Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Weeks 0 to 36 | Full Analysis Population: All randomized participants who received at least one dose of study medication | percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) | Weeks 29 to 36 | Full Analysis Population: All randomized participants who received at least one dose of study medication | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Peginesatide | Baseline [N=524, 269] | 11.30 | Standard Deviation 0.523 | g/dL |
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Epoetin Alfa | Baseline [N=524, 269] | 11.32 | Standard Deviation 0.493 | g/dL |
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Peginesatide | Evaluation Period [N=445, 248] | 11.06 | Standard Deviation 0.932 | g/dL |
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Epoetin Alfa | Evaluation Period [N=445, 248] | 11.25 | Standard Deviation 0.846 | g/dL |
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Peginesatide | Change from Baseline [N=445, 248] | -0.24 | Standard Deviation 0.956 | g/dL |
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Epoetin Alfa | Change from Baseline [N=445, 248] | -0.09 | Standard Deviation 0.922 | g/dL |
| Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Peginesatide | 0.103 | percentage of participants | ||
| Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods | Epoetin Alfa | 0.086 | percentage of participants | ||
| Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) | Peginesatide | 0.630 | percentage of participants | ||
| Proportion of Participants Whose Mean Hemoglobin Level During the Evaluation Period is Within the Target Range of 10.0 - 12.0 Grams Per Deciliter (g/dL) | Epoetin Alfa | 0.717 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peginesatide | 532 | |
| Overall Study | STARTED | Epoetin Alfa | 271 | |
| Overall Study | COMPLETED | Peginesatide | 366 | |
| Overall Study | COMPLETED | Epoetin Alfa | 202 | |
| Overall Study | NOT COMPLETED | Peginesatide | 166 | |
| Overall Study | NOT COMPLETED | Epoetin Alfa | 69 |
Source ClinicalTrials.gov
Adverse events1,010
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Peginesatide | 98 | 524 | |
| other | Diarrhoea | Gastrointestinal disorders | Epoetin Alfa | 35 | 269 | |
| other | Nausea | Gastrointestinal disorders | Peginesatide | 89 | 524 | |
| other | Nausea | Gastrointestinal disorders | Epoetin Alfa | 51 | 269 | |
| other | Vomiting | Gastrointestinal disorders | Peginesatide | 86 | 524 | |
| other | Vomiting | Gastrointestinal disorders | Epoetin Alfa | 32 | 269 | |
| other | Constipation | Gastrointestinal disorders | Peginesatide | 37 | 524 | |
| other | Constipation | Gastrointestinal disorders | Epoetin Alfa | 33 | 269 | |
| other | Abdominal pain | Gastrointestinal disorders | Peginesatide | 31 | 524 | |
| other | Abdominal pain | Gastrointestinal disorders | Epoetin Alfa | 20 | 269 |
1 to 10 of 1,010Source ClinicalTrials.gov
See all 1,010 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peginesatide | ||
| Total, all-cause mortality | Epoetin Alfa | ||
| Total, other adverse events | Peginesatide | 445 | 524 |
| Total, other adverse events | Epoetin Alfa | 235 | 269 |
| Total, serious adverse events | Peginesatide | 304 | 524 |
| Total, serious adverse events | Epoetin Alfa | 168 | 269 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Peginesatide vs Epoetin Alfa: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00597753
GET https://conductscience.org/api/trials/v1/NCT00597753/events?page=2