Trial · NCT00598442

Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis

NCT00598442, Phase 3, Completed, Affymax; results first posted 2012-07-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis. Trials, record NCT00598442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00598442

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
NCT number: NCT00598442
Status: Completed
Phases: Phase 3
Enrollment: 493 participants, actual
Lead sponsor: Affymax
Conditions: Chronic Renal Failure, Chronic Kidney Disease, Anemia
Interventions: peginesatide, peginesatide, Darbepoetin alfa
First posted: 2008-01-21
Last updated: 2013-02-12
Other registries' IDs: eudract:2007-004146-32
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 25-36	The baseline hemoglobin value is defined as the mean of three hemoglobin values: the two 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 25 through 36.
Secondary	Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods	Weeks 0 to 36
Secondary	Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods	Weeks 0 to 36	A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 gram per deciliter (g/dL) above baseline and a hemoglobin ≥ 11.0 g/dL without RBC transfusion during the previous 8 weeks.

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 25-36	Full Analysis Population: All randomized participants who received at least one dose of study medication	g/dL	MEAN
SECONDARY	Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction 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 Achieving Hemoglobin Response During the Correction 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

Source ClinicalTrials.gov

Results by group15

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 0.025 mg/kg	Baseline [N=167, 163, 163]	10.02	Standard Deviation 0.626	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.04 mg/kg	Baseline [N=167, 163, 163]	10.03	Standard Deviation 0.618	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Darbepoetin Alfa	Baseline [N=167, 163, 163]	10.03	Standard Deviation 0.654	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.025 mg/kg	Evaluation Period [N=151, 145, 150]	11.55	Standard Deviation 0.741	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.04 mg/kg	Evaluation Period [N=151, 145, 150]	11.71	Standard Deviation 0.855	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Darbepoetin Alfa	Evaluation Period [N=151, 145, 150]	11.40	Standard Deviation 0.728	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.025 mg/kg	Change from Baseline [N=151, 145, 150]	1.50	Standard Deviation 0.898	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.04 mg/kg	Change from Baseline [N=151, 145, 150]	1.68	Standard Deviation 0.962	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Darbepoetin Alfa	Change from Baseline [N=151, 145, 150]	1.35	Standard Deviation 1.004	g/dL
Proportion of Participants Who Received Red Blood Cell (RBC) Transfusions During the Correction and Evaluation Periods	Peginesatide 0.025 mg/kg		0.114		percentage of participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Peginesatide 0.025 mg/kg	167
Overall Study	STARTED	Peginesatide 0.04 mg/kg	163
Overall Study	STARTED	Darbepoetin Alfa	163
Overall Study	COMPLETED	Peginesatide 0.025 mg/kg	124
Overall Study	COMPLETED	Peginesatide 0.04 mg/kg	124
Overall Study	COMPLETED	Darbepoetin Alfa	139
Overall Study	NOT COMPLETED	Peginesatide 0.025 mg/kg	43
Overall Study	NOT COMPLETED	Peginesatide 0.04 mg/kg	39
Overall Study	NOT COMPLETED	Darbepoetin Alfa	24

Source ClinicalTrials.gov

Adverse events1,008

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	Anaemia	Blood and lymphatic system disorders	Peginesatide 0.025 mg/kg	13	167
other	Anaemia	Blood and lymphatic system disorders	Peginesatide 0.04 mg/kg	9	163
other	Anaemia	Blood and lymphatic system disorders	Darbepoetin Alfa	4	163
other	Hyperparathyroidism	Endocrine disorders	Peginesatide 0.025 mg/kg	8	167
other	Hyperparathyroidism	Endocrine disorders	Peginesatide 0.04 mg/kg	4	163
other	Hyperparathyroidism	Endocrine disorders	Darbepoetin Alfa	9	163
other	Hyperparathyroidism secondary	Endocrine disorders	Peginesatide 0.025 mg/kg	5	167
other	Hyperparathyroidism secondary	Endocrine disorders	Peginesatide 0.04 mg/kg	9	163
other	Hyperparathyroidism secondary	Endocrine disorders	Darbepoetin Alfa	6	163
other	Nausea	Gastrointestinal disorders	Peginesatide 0.025 mg/kg	27	167

1 to 10 of 1,008Source ClinicalTrials.gov

See all 1,008 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Peginesatide 0.025 mg/kg
Total, all-cause mortality	Peginesatide 0.04 mg/kg
Total, all-cause mortality	Darbepoetin Alfa
Total, other adverse events	Peginesatide 0.025 mg/kg	142	167
Total, other adverse events	Peginesatide 0.04 mg/kg	134	163
Total, other adverse events	Darbepoetin Alfa	134	163
Total, serious adverse events	Peginesatide 0.025 mg/kg	86	167
Total, serious adverse events	Peginesatide 0.04 mg/kg	80	163
Total, serious adverse events	Darbepoetin Alfa	70	163

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23343061	DERIVED	PubMed
23343062	RESULT	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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/NCT00598442

GET https://conductscience.org/api/trials/v1/NCT00598442/events?page=2

API reference For AI assistants