Phase 2
Completed N=102
Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
Source: ClinicalTrials.gov NCT00752609 ↗Enrolled (actual)
102
Serious AEs
21.8%
Results posted
Jul 2012
Primary outcomePrimary: Mean Change in Hemoglobin Between Baseline and the Evaluation Period — 11.22; 11.11; 10.78; 11.64 g/dL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Hemoglobin Between Baseline and the Evaluation Period |
11.22; 11.11; 10.78; 11.64; -0.42; 0.49 | — |
| SECONDARY Percentage of Participants With Hemoglobin Within the Target Range of 10.0 to 12.0 g/dL During the Evaluation Period |
73.3; 68.1 | — |
| SECONDARY Percentage of Participants With a Change in Hemoglobin From Baseline to the Evaluation Period Within 1 g/dL |
80.0; 68.1 | — |
| SECONDARY Percentage of Participants With Red Blood Cell Transfusions |
5.8; 2.0; 5.8; 2.0; 0; 0 | — |
| SECONDARY Mean Hemoglobin During 4-week Intervals |
11.54; 11.74; 11.16; 11.94; 10.99; 11.95 | — |
| SECONDARY Percentage of Participants With Target Hemoglobin of 10.0 to 12.0 g/dL by 4-week Intervals. |
71.2; 69.4; 81.6; 51.0; 77.6; 44.7 | — |
| SECONDARY Percentage of Participants With Dose Adjustments During the Study |
81.8; 80.0; 81.6; 31.6; 60.0; 43.2 | — |
Eligibility Criteria
Inclusion Criteria
- The patient was a man or woman 18 to 90 years of age, inclusive.
- The patient had CKD and met 1 of the following criteria:
- Had been on dialysis for ≥6 months prior to enrollment, or
- Had not yet begun dialysis (hemodialysis or peritoneal dialysis) and was not anticipated to require initiation of dialysis during participation in the study.
- The patient was on stable darbepoetin alfa maintenance therapy (either SC or IV) continuously for a minimum of 8 weeks prior to enrollment.
- 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
- The patient had known bleeding or coagulation disorder.
- 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).
- 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).
- The patient had advanced chronic CKD defined by New York Heart Association Class III or IV.
- The patient had a known history of seizure disorder or received antiepileptic medication for a seizure disorder within 6 months prior to enrollment.
- The patient had a scheduled kidney transplant. Patients currently on a transplant waiting list were not excluded, unless there was an identified donor.
Data sourced from ClinicalTrials.gov (NCT00752609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.