Trial · NCT00680043

Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA

NCT00680043, Phase 2, Completed, Affymax; results first posted 2012-05-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA. Trials, record NCT00680043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680043

On this page

Trial

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

Title: Safety & Efficacy of Peginesatide for Treatment of Anemia in Participants on Dialysis Not Receiving an ESA
NCT number: NCT00680043
Status: Completed
Phases: Phase 2
Enrollment: 114 participants, actual
Lead sponsor: Affymax
Conditions: Anemia, Chronic Renal Failure, Chronic Kidney Disease
Interventions: peginesatide, peginesatide, Epoetin Alfa
First posted: 2008-05-19
Last updated: 2012-06-29
Results first posted: 2012-05-30

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 21-28	The baseline hemoglobin value is defined as the mean of the two most recent hemoglobin values taken prior to the day of randomization plus the value obtained on the day of randomization prior to Dose 1. The mean hemoglobin during the Evaluation period for each participant is calculated as the mean of the available hemoglobin values during Study Weeks 21 through 28.
Secondary	Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods	Weeks 1 to 28
Secondary	Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods	Weeks 1 to 28	A hemoglobin response is defined as a hemoglobin increase of ≥ 1.0 g/dL above baseline and a hemoglobin ≥ 11.0 g/dL without RBC or whole blood 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 21-28	Full Analysis Population	g/dL	MEAN
SECONDARY	Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods	Weeks 1 to 28	Full Analysis Population	percentage of participants	NUMBER
SECONDARY	Proportion of Participants Achieving Hemoglobin Response During the Correction and Evaluation Periods	Weeks 1 to 28	Full Analysis Population	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 0.04 mg/kg	Baseline [N=39, 37, 38]	9.34	Standard Deviation 0.738	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.08 mg/kg	Baseline [N=39, 37, 38]	9.20	Standard Deviation 0.701	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Epoetin Alfa	Baseline [N=39, 37, 38]	9.07	Standard Deviation 0.739	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.04 mg/kg	Evaluation Period [N=37, 37, 36]	11.45	Standard Deviation 1.101	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.08 mg/kg	Evaluation Period [N=37, 37, 36]	11.59	Standard Deviation 0.943	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Epoetin Alfa	Evaluation Period [N=37, 37, 36]	11.49	Standard Deviation 0.775	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.04 mg/kg	Change from Baseline [N=37, 37, 36]	2.15	Standard Deviation 1.038	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Peginesatide 0.08 mg/kg	Change from Baseline [N=37, 37, 36]	2.39	Standard Deviation 0.974	g/dL
Mean Change in Hemoglobin Between Baseline and the Evaluation Period	Epoetin Alfa	Change from Baseline [N=37, 37, 36]	2.41	Standard Deviation 0.991	g/dL
Proportion of Participants Who Receive Red Blood Cell (RBC) or Whole Blood Transfusions During the Correction and Evaluation Periods	Peginesatide 0.04 mg/kg		0.026		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 0.04 mg/kg	39
Overall Study	STARTED	Peginesatide 0.08 mg/kg	37
Overall Study	STARTED	Epoetin Alfa	38
Overall Study	COMPLETED	Peginesatide 0.04 mg/kg	37
Overall Study	COMPLETED	Peginesatide 0.08 mg/kg	36
Overall Study	COMPLETED	Epoetin Alfa	34
Overall Study	NOT COMPLETED	Peginesatide 0.04 mg/kg	2
Overall Study	NOT COMPLETED	Peginesatide 0.08 mg/kg	1
Overall Study	NOT COMPLETED	Epoetin Alfa	4

Source ClinicalTrials.gov

Adverse events153

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	Angina pectoris	Cardiac disorders	Peginesatide 0.04 mg/kg	1	39
other	Angina pectoris	Cardiac disorders	Peginesatide 0.08 mg/kg	1	37
other	Angina pectoris	Cardiac disorders	Epoetin Alfa	4	38
other	Palpitations	Cardiac disorders	Peginesatide 0.04 mg/kg	1	39
other	Palpitations	Cardiac disorders	Peginesatide 0.08 mg/kg	0	37
other	Palpitations	Cardiac disorders	Epoetin Alfa	2	38
other	Hyperparathyroidism secondary	Endocrine disorders	Peginesatide 0.04 mg/kg	3	39
other	Hyperparathyroidism secondary	Endocrine disorders	Peginesatide 0.08 mg/kg	1	37
other	Hyperparathyroidism secondary	Endocrine disorders	Epoetin Alfa	4	38
other	Diarrhoea	Gastrointestinal disorders	Peginesatide 0.04 mg/kg	1	39

1 to 10 of 153Source ClinicalTrials.gov

See all 153 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Peginesatide 0.04 mg/kg
Total, all-cause mortality	Peginesatide 0.08 mg/kg
Total, all-cause mortality	Epoetin Alfa
Total, other adverse events	Peginesatide 0.04 mg/kg	21	39
Total, other adverse events	Peginesatide 0.08 mg/kg	26	37
Total, other adverse events	Epoetin Alfa	27	38
Total, serious adverse events	Peginesatide 0.04 mg/kg	6	39
Total, serious adverse events	Peginesatide 0.08 mg/kg	8	37
Total, serious adverse events	Epoetin Alfa	4	38

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT00680043

GET https://conductscience.org/api/trials/v1/NCT00680043/events?page=2

API reference For AI assistants