Trial Outcomes & Findings for Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis (NCT NCT00434330)
NCT ID: NCT00434330
Last Updated: 2012-06-29
Results Overview
The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Baseline and Weeks 2-29
Results posted on
2012-06-29
Participant Flow
Participant milestones
| Measure |
Cohort 1, Q4W, SC, No Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
16
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
13
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1, Q4W, SC, No Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Renal transplant
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject Not Compliant With Study
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Peginesatide for Maintenance Treatment of Anemia in Participants on Hemodialysis
Baseline characteristics by cohort
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=16 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
70 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Age Continuous
|
53.4 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 13.91 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 17.22 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 12.47 • n=4 Participants
|
51.1 years
STANDARD_DEVIATION 11.43 • n=21 Participants
|
53 years
STANDARD_DEVIATION 13.22 • n=8 Participants
|
51.9 years
STANDARD_DEVIATION 13.74 • n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
57 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Weeks 2-29Population: Modified intent-to-treat (mITT) population
The Baseline hemoglobin was the mean of the four most recent mid- or end-of-week predialysis hemoglobin values collected prior to study start. Study start was the date of the first dose of peginesatide injection in participants who did not have a one-week transition period, or the date when Epoetin treatment was first withheld in participants who did have a one-week transition period.
Outcome measures
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.
Weeks 2-29 [N=15, 15, 15, 15, 15, 15]
|
11.64 g/dL
Standard Deviation 0.722
|
11.57 g/dL
Standard Deviation 0.771
|
11.98 g/dL
Standard Deviation 0.858
|
11.86 g/dL
Standard Deviation 0.538
|
11.92 g/dL
Standard Deviation 0.699
|
11.19 g/dL
Standard Deviation 1.114
|
|
Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.
Change from Baseline [N=15, 15, 14, 15, 15, 15]
|
0.53 g/dL
Standard Deviation 0.600
|
0.23 g/dL
Standard Deviation 0.776
|
0.57 g/dL
Standard Deviation 0.793
|
0.67 g/dL
Standard Deviation 0.752
|
0.82 g/dL
Standard Deviation 0.935
|
-0.05 g/dL
Standard Deviation 1.000
|
|
Mean Hemoglobin Throughout the Trial and Mean Hemoglobin Change From Baseline Throughout the Trial.
Baseline [N=15, 15, 14, 15, 15, 15]
|
11.10 g/dL
Standard Deviation 0.600
|
11.34 g/dL
Standard Deviation 0.596
|
11.42 g/dL
Standard Deviation 0.448
|
11.19 g/dL
Standard Deviation 0.628
|
11.11 g/dL
Standard Deviation 0.810
|
11.24 g/dL
Standard Deviation 0.742
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 2 to 29Population: mITT population
Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within 1 g/dL below to 1.5 g/dL above baseline) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.
Outcome measures
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants With Hemoglobin Within 1.0 g/dL Below Baseline to 1.5 g/dL Above Baseline Throughout the Trial (Weeks 2-29)
|
0.267 percentage of participants
|
0.133 percentage of participants
|
0.200 percentage of participants
|
0.333 percentage of participants
|
0.400 percentage of participants
|
0.267 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 2 to 29Population: mITT population
Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 10 g/dL to 12.5 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.
Outcome measures
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants Who Maintained Hemoglobin Within 10 to 12.5 g/dL Throughout the Trial
|
0.333 percentage of participants
|
0.200 percentage of participants
|
0.200 percentage of participants
|
0.200 percentage of participants
|
0.200 percentage of participants
|
0.067 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Weeks 2 to 29Population: mITT population
Hemoglobin relative to baseline: Hemoglobin at a given time point was considered to be not within the specified range (within the range of 9.5 g/dL to 13.0 g/dL) if the hemoglobin value at the time point was not within the range and the next available hemoglobin value within 14 days after the time point also was not within the specified range. These calculations were determined for all time points within a specified time period.
Outcome measures
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 Participants
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Proportion of Participants Who Maintain Hemoglobin Within 9.5 to 13.0 g/dL Throughout the Trial
|
0.800 percentage of participants
|
0.667 percentage of participants
|
0.533 percentage of participants
|
0.533 percentage of participants
|
0.600 percentage of participants
|
0.600 percentage of participants
|
Adverse Events
Cohort 1, Q4W, SC, No Transition
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2, Q4W, IV, No Transition
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 3, Q4W, SC, Transition
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Cohort 4, Q4W, IV, Transition
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 5, Q4W, SC, Transition
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 6, Q4W, IV, Transition
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=16 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/15
|
0.00%
0/15
|
12.5%
2/16
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/15
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
|
General disorders
Sudden death
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
13.3%
2/15
|
6.7%
1/15
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/15
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Eye disorders
Keratitis
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/16
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Eye disorders
Uveitis
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/16
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Vascular disorders
Penile necrosis
|
0.00%
0/15
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
6.7%
1/15
|
0.00%
0/15
|
Other adverse events
| Measure |
Cohort 1, Q4W, SC, No Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 2, Q4W, IV, No Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 3, Q4W, SC, Transition
n=16 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 4, Q4W, IV, Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, \>100 to 150 Units/kg/week, or \>150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 5, Q4W, SC, Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
Cohort 6, Q4W, IV, Transition
n=15 participants at risk
Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
26.7%
4/15
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
6.7%
1/15
|
0.00%
0/15
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15
|
6.7%
1/15
|
12.5%
2/16
|
0.00%
0/15
|
13.3%
2/15
|
6.7%
1/15
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
3/15
|
0.00%
0/15
|
18.8%
3/16
|
0.00%
0/15
|
0.00%
0/15
|
6.7%
1/15
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15
|
13.3%
2/15
|
6.2%
1/16
|
26.7%
4/15
|
6.7%
1/15
|
0.00%
0/15
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
6.7%
1/15
|
0.00%
0/16
|
6.7%
1/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15
|
6.7%
1/15
|
6.2%
1/16
|
6.7%
1/15
|
6.7%
1/15
|
6.7%
1/15
|
|
General disorders
Chest pain
|
0.00%
0/15
|
20.0%
3/15
|
6.2%
1/16
|
6.7%
1/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Infections and infestations
Bronchitis
|
26.7%
4/15
|
20.0%
3/15
|
6.2%
1/16
|
0.00%
0/15
|
13.3%
2/15
|
6.7%
1/15
|
|
Infections and infestations
Tracheobronchitis
|
20.0%
3/15
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/15
|
13.3%
2/15
|
6.7%
1/15
|
|
Infections and infestations
Tooth abscess
|
13.3%
2/15
|
0.00%
0/15
|
0.00%
0/16
|
6.7%
1/15
|
13.3%
2/15
|
0.00%
0/15
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/15
|
20.0%
3/15
|
0.00%
0/16
|
13.3%
2/15
|
0.00%
0/15
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
|
20.0%
3/15
|
20.0%
3/15
|
18.8%
3/16
|
6.7%
1/15
|
0.00%
0/15
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
6.7%
1/15
|
6.7%
1/15
|
12.5%
2/16
|
6.7%
1/15
|
6.7%
1/15
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/15
|
20.0%
3/15
|
12.5%
2/16
|
6.7%
1/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/15
|
13.3%
2/15
|
0.00%
0/16
|
20.0%
3/15
|
0.00%
0/15
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Procedural hypertension
|
0.00%
0/15
|
13.3%
2/15
|
0.00%
0/16
|
20.0%
3/15
|
26.7%
4/15
|
20.0%
3/15
|
|
Investigations
Blood pressure increased
|
26.7%
4/15
|
0.00%
0/15
|
12.5%
2/16
|
0.00%
0/15
|
13.3%
2/15
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
33.3%
5/15
|
26.7%
4/15
|
12.5%
2/16
|
26.7%
4/15
|
26.7%
4/15
|
26.7%
4/15
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15
|
0.00%
0/15
|
12.5%
2/16
|
0.00%
0/15
|
6.7%
1/15
|
6.7%
1/15
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.3%
2/15
|
6.7%
1/15
|
0.00%
0/16
|
6.7%
1/15
|
13.3%
2/15
|
0.00%
0/15
|
|
Nervous system disorders
Headache
|
60.0%
9/15
|
26.7%
4/15
|
43.8%
7/16
|
26.7%
4/15
|
33.3%
5/15
|
26.7%
4/15
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15
|
0.00%
0/15
|
12.5%
2/16
|
0.00%
0/15
|
20.0%
3/15
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
3/15
|
6.7%
1/15
|
18.8%
3/16
|
0.00%
0/15
|
20.0%
3/15
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
2/15
|
0.00%
0/15
|
6.2%
1/16
|
6.7%
1/15
|
13.3%
2/15
|
0.00%
0/15
|
|
Vascular disorders
Hypotension
|
40.0%
6/15
|
33.3%
5/15
|
12.5%
2/16
|
13.3%
2/15
|
13.3%
2/15
|
13.3%
2/15
|
|
Vascular disorders
Hypertensive crisis
|
26.7%
4/15
|
40.0%
6/15
|
12.5%
2/16
|
33.3%
5/15
|
0.00%
0/15
|
26.7%
4/15
|
|
Vascular disorders
Hypertension
|
13.3%
2/15
|
13.3%
2/15
|
25.0%
4/16
|
26.7%
4/15
|
6.7%
1/15
|
0.00%
0/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publications may not contain Sponsor confidential information, and will be subject to Sponsor review prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER