Anemia
Conditions
Keywords
Anemia, Drug Therapy, Hemodialysis, Kidney Failure
Brief summary
The purpose of this study is to determine the efficacy and safety of Peginesatide Injection for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis or do not require dialysis and who were previously treated with Darbepoetin Alfa.
Detailed description
Anemia, resulting primarily from insufficient production of erythropoietin to support erythropoiesis, is a common consequence of chronic renal failure. Both North America and Europe have established clinical practice guidelines for the treatment and hemoglobin targets in chronic renal failure/chronic kidney disease patients. These guidelines recommend the use of erythropoiesis-stimulating agents (ESAs). The benefits of ESA therapy include reduced fatigue, improved quality of life, decreased cardiovascular mortality risk and improved cardiovascular function. An increased risk of death and serious cardiovascular and thromboembolic events, including myocardial infarction, stroke, congestive heart failure, and hemodialysis graft occlusion have been observed in controlled clinical trials of ESAs when administered to target hemoglobin levels of ≥13.5 g/dL. The vast majority of patients receiving hemodialysis receive ESA therapy to treat their anemia and most patients begin ESA therapy prior to any requirement for dialysis. Anemia of chronic renal failure is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors also include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anemia increases with progressive deterioration of renal function, and affects more than 90% of patients with chronic renal failure Stage 5 (End Stage Renal Disease). Anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of anemia reduces morbidity and mortality risks and may improve quality of life. Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic renal failure participants, and have improved the management of anemia over alternatives such as transfusion. Peginesatide (hematide) is a parenteral formulation being developed for the correction of anemia in patients with chronic renal failure, and binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents. Participants in this study received variable doses of peginesatide injection once every four weeks. Total commitment time for this study was about 30 weeks.
Interventions
DRUGPeginesatide
Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
Sponsors
Affymax
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. The patient was a man or woman 18 to 90 years of age, inclusive. 2. The patient had CKD and met 1 of the following criteria: 1. Had been on dialysis for ≥6 months prior to enrollment, or 2. Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not anticipated to require initiation of dialysis during participation in the study. 3. The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment. 4. The patient had 4 consecutive Hb values with a mean ≥10.0 and ≤12.0 g/dL during screening period, with the difference between the mean of the first 2 consecutive Hb values and the mean of the last 2 consecutive values being ≤1.0 g/dL.
Exclusion criteria
1. The patient had known bleeding or coagulation disorder. 2. The patient had known hematologic disease or cause of anemia other than renal disease (i.e., pure red cell aplasia, homozygous sickle-cell disease, thalassemia, multiplemyeloma, hemolytic anemia, and myelodysplastic syndrome). 3. The patient had received a recent course of intensive iron replacement (i.e., more than 500 mg IV in the 28 days prior to enrollment). 4. The patient had advanced chronic CKD defined by New York Heart Association Class III or IV. 5. The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrollment. 6. The patient had a scheduled kidney transplant. Patients currently on a transplant waiting list were not excluded, unless there was an identified donor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Baseline and Week 19 to Week 24. | Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Dose Adjustments During the Study | From Week 4 to Week 20 | The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was \>20% higher or \>20% lower respectively, than the previous dose. |
| Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period | Week 19 to Week 24 | Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction. |
| Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Up to 24 weeks. | Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. |
| Percentage of Participants With Red Blood Cell Transfusions | Up to 24 weeks. | The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction. |
| Mean Hemoglobin During 4-week Intervals | Up to 24 weeks. | Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). |
| Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL | Baseline and Week 19 to Week 24. | Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction. |
Countries
United States
Participant flow
Recruitment details
Participants enrolled at 18 investigative sites in the United Kingdom, Italy, Australia, and the United States from 22 September 2008 to 24 December 2009.
Pre-assignment details
Participants with a diagnosis of chronic renal failure (on hemodialysis or not on dialysis) and receiving stable Darbepoetin alfa maintenance therapy were enrolled into one treatment group (peginesatide injection).
Participants by arm
| Arm | Count |
|---|---|
| Peginesatide - On Dialysis Participants on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. | 52 |
| Peginesatide - Not on Dialysis Participants not on dialysis received peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline. | 49 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Met exclusion criteria | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Received Aranesp in error | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Peginesatide - On Dialysis | Peginesatide - Not on Dialysis | Total |
|---|---|---|---|
| Age Continuous | 66.4 years STANDARD_DEVIATION 12.6 | 68.6 years STANDARD_DEVIATION 12.07 | 67.5 years STANDARD_DEVIATION 12.33 |
| Age, Customized ≥65 - <75 years | 13 participants | 13 participants | 26 participants |
| Age, Customized < 65 years | 22 participants | 18 participants | 40 participants |
| Age, Customized ≥ 75 | 17 participants | 18 participants | 35 participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 50 Participants |
| Sex: Female, Male Male | 35 Participants | 16 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 31 / 52 | 28 / 49 |
| serious Total, serious adverse events | 16 / 52 | 6 / 49 |
Outcome results
Primary
Mean Change in Hemoglobin Between Baseline and the Evaluation Period
Mean change in Hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin from Weeks 19 to 24).
Time frame: Baseline and Week 19 to Week 24.
Population: The Full Analysis Set including all patients who received at least 1 dose of study drug where data was available (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginesatide - On Dialysis | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Baseline [N=52, 49] | 11.22 g/dL | Standard Deviation 0.514 |
| Peginesatide - On Dialysis | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Evaluation Period [N=45, 47] | 10.78 g/dL | Standard Deviation 0.845 |
| Peginesatide - On Dialysis | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Change from Baseline [N=45, 47] | -0.42 g/dL | Standard Deviation 0.761 |
| Peginesatide - Not on Dialysis | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Baseline [N=52, 49] | 11.11 g/dL | Standard Deviation 0.447 |
| Peginesatide - Not on Dialysis | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Evaluation Period [N=45, 47] | 11.64 g/dL | Standard Deviation 0.673 |
| Peginesatide - Not on Dialysis | Mean Change in Hemoglobin Between Baseline and the Evaluation Period | Change from Baseline [N=45, 47] | 0.49 g/dL | Standard Deviation 0.769 |
95% CI: [-0.65, -0.19]
95% CI: [0.26, 0.71]
Secondary
Mean Hemoglobin During 4-week Intervals
Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24).
Time frame: Up to 24 weeks.
Population: Full Analysis Set where data was available for each time interval (indicated by N).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginesatide - On Dialysis | Mean Hemoglobin During 4-week Intervals | Week 5-8 [N=49, 49] | 11.16 g/dL | Standard Deviation 0.876 |
| Peginesatide - On Dialysis | Mean Hemoglobin During 4-week Intervals | Week 1-4 [N=52, 49] | 11.54 g/dL | Standard Deviation 0.728 |
| Peginesatide - On Dialysis | Mean Hemoglobin During 4-week Intervals | Week 17-20 [N=46, 47] | 10.78 g/dL | Standard Deviation 0.989 |
| Peginesatide - On Dialysis | Mean Hemoglobin During 4-week Intervals | Week 9-12 [N=49, 47] | 10.99 g/dL | Standard Deviation 0.919 |
| Peginesatide - On Dialysis | Mean Hemoglobin During 4-week Intervals | Week 21-24 [N=44, 47] | 10.81 g/dL | Standard Deviation 0.827 |
| Peginesatide - On Dialysis | Mean Hemoglobin During 4-week Intervals | Week 13-16 [N=47, 46] | 10.64 g/dL | Standard Deviation 0.975 |
| Peginesatide - Not on Dialysis | Mean Hemoglobin During 4-week Intervals | Week 21-24 [N=44, 47] | 11.58 g/dL | Standard Deviation 0.687 |
| Peginesatide - Not on Dialysis | Mean Hemoglobin During 4-week Intervals | Week 1-4 [N=52, 49] | 11.74 g/dL | Standard Deviation 0.863 |
| Peginesatide - Not on Dialysis | Mean Hemoglobin During 4-week Intervals | Week 5-8 [N=49, 49] | 11.94 g/dL | Standard Deviation 0.917 |
| Peginesatide - Not on Dialysis | Mean Hemoglobin During 4-week Intervals | Week 9-12 [N=49, 47] | 11.95 g/dL | Standard Deviation 0.837 |
| Peginesatide - Not on Dialysis | Mean Hemoglobin During 4-week Intervals | Week 13-16 [N=47, 46] | 11.95 g/dL | Standard Deviation 0.815 |
| Peginesatide - Not on Dialysis | Mean Hemoglobin During 4-week Intervals | Week 17-20 [N=46, 47] | 11.84 g/dL | Standard Deviation 0.747 |
Secondary
Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL
Percentage of participants with a mean change in hemoglobin between Baseline (the mean of the 4 most recent hemoglobin values prior to enrollment and the hemoglobin on the day of enrollment) and the Evaluation Period (mean hemoglobin measured at Weeks 19 to 24) of less than or equal ± 1 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.
Time frame: Baseline and Week 19 to Week 24.
Population: Full analysis set where data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginesatide - On Dialysis | Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL | 80.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL | 68.1 percentage of participants |
Secondary
Percentage of Participants With Dose Adjustments During the Study
The peginesatide dose was adjusted to maintain Hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline during the Titration Period (Weeks 0-18) and Evaluation Period (Weeks 19-24). A dose was classified as adjusted if it was not within 20% of the previous dose. A dose was classified as increased or decreased if it was \>20% higher or \>20% lower respectively, than the previous dose.
Time frame: From Week 4 to Week 20
Population: Safety Analysis set, which included all patients who received at least 1 dose of study drug. N indicates the number of patients with study drug administered during the period after excluding the initial dose of study drug and excluding the first dose after a restart of study drug and is the denominator for percentage calculations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased in Titration Period [N=44, 5, 49] | 56.8 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased during entire study [N=44, 5, 49] | 59.1 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased during entire study [N=44, 5, 49] | 65.9 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased in Evaluation Period [N=38, 5, 44] | 21.1 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment in Titration Period [N=44, 5, 49] | 81.8 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased in Evaluation Period [N=38, 5, 44] | 13.2 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment during entire study [N=44, 5, 49] | 90.9 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment in Evaluation Period [N=38, 5, 44] | 31.6 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased in Titration Period [N=44, 5, 49] | 50.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased in Evaluation Period [N=38, 5, 44] | 40.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment in Titration Period [N=44, 5, 49] | 80.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment in Evaluation Period [N=38, 5, 44] | 60.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment during entire study [N=44, 5, 49] | 80.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased in Titration Period [N=44, 5, 49] | 40.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased during entire study [N=44, 5, 49] | 60.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased in Titration Period [N=44, 5, 49] | 60.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased in Evaluation Period [N=38, 5, 44] | 20.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased during entire study [N=44, 5, 49] | 60.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment during entire study [N=44, 5, 49] | 87.8 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment in Titration Period [N=44, 5, 49] | 81.6 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased in Titration Period [N=44, 5, 49] | 73.5 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Any adjustment in Evaluation Period [N=38, 5, 44] | 43.2 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased during entire study [N=44, 5, 49] | 79.6 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased in Evaluation Period [N=38, 5, 44] | 2.3 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased in Titration Period [N=44, 5, 49] | 10.2 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose decreased in Evaluation Period [N=38, 5, 44] | 40.9 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Dose Adjustments During the Study | Dose increased during entire study [N=44, 5, 49] | 12.2 percentage of participants |
Secondary
Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period
Mean hemoglobin was calculated from measurements taken during the Evaluation Period from Week 19 to Week 24. The target hemoglobin range was between 10.0 to 12.0 g/dL. The 95% confidence interval was calculated from the normal approximation with continuity correction.
Time frame: Week 19 to Week 24
Population: Full Analysis Set where data was available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginesatide - On Dialysis | Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period | 73.3 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period | 68.1 percentage of participants |
Secondary
Percentage of Participants With Red Blood Cell Transfusions
The percentage of participants who received one or more red blood cell transfusions, including packed red blood cells and whole blood transfusions, during the Titration Period (Weeks 0 - 18) and Evaluation Period (Weeks 19 -24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.
Time frame: Up to 24 weeks.
Population: Full Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginesatide - On Dialysis | Percentage of Participants With Red Blood Cell Transfusions | Entire study | 5.8 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Red Blood Cell Transfusions | Titration Period | 5.8 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Red Blood Cell Transfusions | Evaluation Period | 0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Red Blood Cell Transfusions | Entire study | 2.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Red Blood Cell Transfusions | Titration Period | 2.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Red Blood Cell Transfusions | Evaluation Period | 0 percentage of participants |
Secondary
Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals.
Percentage of participants with mean hemoglobin levels falling between the target level of 10.0 to 12.0 g/dL during 4-week study intervals. Hemoglobin was measured every 2 weeks during the Titration Period (Weeks 0-18) and weekly during the Evaluation Period (Weeks 19-24). 95% Confidence Intervals were calculated from the normal approximation with continuity correction.
Time frame: Up to 24 weeks.
Population: Full analysis set where data was available for each time interval (indicated by N).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginesatide - On Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 1-4 [N=52, 49] | 71.2 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 5-8 [N= 49, 49] | 81.6 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 9-12 [N= 49, 47] | 77.6 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 13-16 [N= 47, 46] | 74.5 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 17-20 [N=46, 47] | 69.6 percentage of participants |
| Peginesatide - On Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 21-24 [N=44, 47] | 79.5 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 17-20 [N=46, 47] | 59.6 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 1-4 [N=52, 49] | 69.4 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 13-16 [N= 47, 46] | 52.2 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 5-8 [N= 49, 49] | 51.0 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 21-24 [N=44, 47] | 63.8 percentage of participants |
| Peginesatide - Not on Dialysis | Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. | Week 9-12 [N= 49, 47] | 44.7 percentage of participants |