Trial · NCT00597584

Safety & Efficacy of Peginesatide for Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease on Hemodialysis

NCT00597584, 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 NCT00597584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00597584

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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: NCT00597584
Status: Completed
Phases: Phase 3
Enrollment: 823 participants, actual
Lead sponsor: Affymax
Conditions: Chronic Renal Failure, Chronic Kidney Disease, Anemia
Interventions: peginesatide, Epoetin alfa or Epoetin beta
First posted: 2008-01-18
Last updated: 2013-03-08
Other registries' IDs: eudract:2007-004153-28
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 to 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 to 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=542, 273]	11.20	Standard Deviation 0.553	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Epoetin	Baseline [N=542, 273]	11.21	Standard Deviation 0.546	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide	Evaluation Period [N=488, 237]	11.13	Standard Deviation 1.018	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Epoetin	Evaluation Period [N=488, 237]	11.05	Standard Deviation 0.958	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide	Change from Baseline [N=488, 237]	-0.07	Standard Deviation 1.009	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Epoetin	Change from Baseline [N=488, 237]	-0.17	Standard Deviation 1.000	g/dL
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods	Peginesatide		0.077		percentage of participants
Proportion of Participants Who Receive Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods	Epoetin		0.099		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		0.635		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		0.659		percentage of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Peginesatide	549
Overall Study	STARTED	Epoetin	274
Overall Study	COMPLETED	Peginesatide	421
Overall Study	COMPLETED	Epoetin	211
Overall Study	NOT COMPLETED	Peginesatide	128
Overall Study	NOT COMPLETED	Epoetin	63

Source ClinicalTrials.gov

Adverse events912

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
other	Nausea	Gastrointestinal disorders	Peginesatide	96	542
other	Nausea	Gastrointestinal disorders	Epoetin	54	273
other	Diarrhoea	Gastrointestinal disorders	Peginesatide	91	542
other	Diarrhoea	Gastrointestinal disorders	Epoetin	47	273
other	Vomiting	Gastrointestinal disorders	Peginesatide	74	542
other	Vomiting	Gastrointestinal disorders	Epoetin	38	273
other	Constipation	Gastrointestinal disorders	Peginesatide	56	542
other	Constipation	Gastrointestinal disorders	Epoetin	27	273
other	Abdominal pain	Gastrointestinal disorders	Peginesatide	51	542
other	Abdominal pain	Gastrointestinal disorders	Epoetin	21	273

1 to 10 of 912Source ClinicalTrials.gov

See all 912 adverse events

Adverse 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
Total, other adverse events	Peginesatide	445	542
Total, other adverse events	Epoetin	222	273
Total, serious adverse events	Peginesatide	268	542
Total, serious adverse events	Epoetin	141	273

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23343061	RESULT	PubMed
23343062	DERIVED	PubMed

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: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00597584

GET https://conductscience.org/api/trials/v1/NCT00597584/events?page=2

API reference For AI assistants