Anemia
Conditions
Keywords
Anemia, Chronic Kidney Disease, End Stage Renal Disease, erythropoiesis-stimulating agents, Hemodialysis, Hemoglobin
Brief summary
The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin.
Detailed description
This is a phase 4, multicenter, single-arm, open-label study designed to evaluate whether patients receiving hemodialysis and treated with peginesatide can be converted to epoetin alfa using a predefined conversion table while achieving stable hemoglobin. The study will be conducted in two phases. Hemodialysis patients treated with epoetin alfa 3 times a week (TIW) will first be converted to peginesatide administered every 4 weeks (Q4W). After 24 weeks, these participants will be converted back to epoetin alfa administered TIW for 32 weeks. The primary endpoint will be the mean hemoglobin during the last 8 weeks of the epoetin alfa period.
Interventions
DRUGPeginesatide
All participants will receive peginesatide for the first 24 weeks.
DRUGEpoetin alfa
All participants converted to epoetin alfa at week 25 for a total of 32 weeks
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Receiving hemodialysis 3 times a week * Receiving epoetin alfa IV 3 times a week * Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening Key
Exclusion criteria
* Systemic hematologic disease * Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Hemoglobin Concentration During the Evaluation Period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Dose of Epoetin Alfa During the Evaluation Period | 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. |
| Hemoglobin Concentration by Visit | Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21 | — |
| Peginesatide Dose by Visit | Baseline and Weeks 5, 9, 13, and 17 | — |
Countries
United States
Participant flow
Recruitment details
First patient was enrolled on 24 October 2012; Last patient was enrolled on 21 February 2013. The study was terminated on 27 March 2013.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Sponsor decision | 40 |
Baseline characteristics
| Characteristic | Peginesatide |
|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 16.6 |
| Race/Ethnicity, Customized Black or African American | 24 participants |
| Race/Ethnicity, Customized Other | 1 participants |
| Race/Ethnicity, Customized White | 16 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 34 |
| serious Total, serious adverse events | 3 / 34 |
Outcome results
Primary
Mean Hemoglobin Concentration During the Evaluation Period
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.
Time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Secondary
Hemoglobin Concentration by Visit
Time frame: Baseline and Weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, and 21
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginesatide | Hemoglobin Concentration by Visit | Week 7 (n=21) | 11.03 g/dL | Standard Deviation 1.02 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 9 (n=20) | 10.59 g/dL | Standard Deviation 0.84 |
| Peginesatide | Hemoglobin Concentration by Visit | Baseline (n=34) | 10.51 g/dL | Standard Deviation 0.76 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 3 (n=34) | 11.09 g/dL | Standard Deviation 0.81 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 5 (n=29) | 10.86 g/dL | Standard Deviation 0.87 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 11 (n=19) | 10.80 g/dL | Standard Deviation 0.97 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 13 (n=14) | 10.50 g/dL | Standard Deviation 0.94 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 15 (n=10) | 10.70 g/dL | Standard Deviation 0.82 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 17 (n=10) | 10.35 g/dL | Standard Deviation 1.31 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 19 (n=10) | 10.93 g/dL | Standard Deviation 0.94 |
| Peginesatide | Hemoglobin Concentration by Visit | Week 21 (n=1) | 10.10 g/dL | — |
| Peginesatide | Hemoglobin Concentration by Visit | End of study visit (n=32) | 10.55 g/dL | Standard Deviation 0.63 |
Secondary
Mean Dose of Epoetin Alfa During the Evaluation Period
No participant reached the evaluation period, therefore, this endpoint could not be evaluated.
Time frame: Last 8 weeks of epoetin alfa treatment period period (Weeks 49 to 56).
Secondary
Peginesatide Dose by Visit
Time frame: Baseline and Weeks 5, 9, 13, and 17
Population: Primary analysis set, with available data at each time point (indicated by n)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginesatide | Peginesatide Dose by Visit | Week 9 (n=15) | 4.98 mg | Standard Deviation 2 |
| Peginesatide | Peginesatide Dose by Visit | Baseline (n=30) | 5.42 mg | Standard Deviation 2.48 |
| Peginesatide | Peginesatide Dose by Visit | Week 5 (n=16) | 5.04 mg | Standard Deviation 1.32 |
| Peginesatide | Peginesatide Dose by Visit | Week 13 (n=9) | 4.00 mg | Standard Deviation 2.53 |
| Peginesatide | Peginesatide Dose by Visit | Week 17 (n=9) | 5.12 mg | Standard Deviation 3.29 |