Trial Outcomes & Findings for Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis (NCT NCT01737879)
NCT ID: NCT01737879
Last Updated: 2014-04-21
Results Overview
The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Results posted on
2014-04-21
Participant Flow
First patient was enrolled on 24 October 2012; Last patient was enrolled on 21 February 2013. The study was terminated on 27 March 2013.
Participant milestones
| Measure |
Peginesatide
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
Received Peginesatide
|
34
|
|
Overall Study
Transitioned to Epoetin Alfa
|
0
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
Peginesatide
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Sponsor decision
|
40
|
Baseline Characteristics
Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
Peginesatide
n=41 Participants
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).The hemoglobin concentrations during the evaluation period after the conversion to epoetin alfa were to be averaged for each participant and then summarized over all participants. No participant reached the evaluation period, therefore, the primary efficacy endpoint could not be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21Population: Primary analysis set includes all enrolled participants who received at least 1 dose of investigational product. The number of participants with available data at each time point is indicated by "n".
Outcome measures
| Measure |
Peginesatide
n=34 Participants
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
Hemoglobin Concentration by Visit
Week 9 (n=20)
|
10.59 g/dL
Standard Deviation 0.84
|
|
Hemoglobin Concentration by Visit
Baseline (n=34)
|
10.51 g/dL
Standard Deviation 0.76
|
|
Hemoglobin Concentration by Visit
Week 3 (n=34)
|
11.09 g/dL
Standard Deviation 0.81
|
|
Hemoglobin Concentration by Visit
Week 5 (n=29)
|
10.86 g/dL
Standard Deviation 0.87
|
|
Hemoglobin Concentration by Visit
Week 7 (n=21)
|
11.03 g/dL
Standard Deviation 1.02
|
|
Hemoglobin Concentration by Visit
Week 11 (n=19)
|
10.80 g/dL
Standard Deviation 0.97
|
|
Hemoglobin Concentration by Visit
Week 13 (n=14)
|
10.50 g/dL
Standard Deviation 0.94
|
|
Hemoglobin Concentration by Visit
Week 15 (n=10)
|
10.70 g/dL
Standard Deviation 0.82
|
|
Hemoglobin Concentration by Visit
Week 17 (n=10)
|
10.35 g/dL
Standard Deviation 1.31
|
|
Hemoglobin Concentration by Visit
Week 19 (n=10)
|
10.93 g/dL
Standard Deviation 0.94
|
|
Hemoglobin Concentration by Visit
Week 21 (n=1)
|
10.10 g/dL
Standard Deviation NA
Data only available for one participant
|
|
Hemoglobin Concentration by Visit
End of study visit (n=32)
|
10.55 g/dL
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 9, 13, and 17Population: Primary analysis set, with available data at each time point (indicated by n)
Outcome measures
| Measure |
Peginesatide
n=34 Participants
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
Peginesatide Dose by Visit
Baseline (n=30)
|
5.42 mg
Standard Deviation 2.48
|
|
Peginesatide Dose by Visit
Week 5 (n=16)
|
5.04 mg
Standard Deviation 1.32
|
|
Peginesatide Dose by Visit
Week 9 (n=15)
|
4.98 mg
Standard Deviation 2.00
|
|
Peginesatide Dose by Visit
Week 13 (n=9)
|
4.00 mg
Standard Deviation 2.53
|
|
Peginesatide Dose by Visit
Week 17 (n=9)
|
5.12 mg
Standard Deviation 3.29
|
Adverse Events
Peginesatide
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginesatide
n=34 participants at risk
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
Cardiac disorders
Ventricular asystole
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Gastroenteritis
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.9%
1/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Peginesatide
n=34 participants at risk
Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
|
|---|---|
|
General disorders
Oedema
|
5.9%
2/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Vascular disorders
Hypertension
|
5.9%
2/34 • From informed consent up to 30 days post treatment, or end of study. Maximum time on study was 6 months.
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER