Abstract | UNLABELLED: ♦ BACKGROUND: METHODS: In this open-label multicenter study, 59 PD patients with CKD were converted from epoetin (alfa or beta) to once-monthly peginesatide. Doses were titrated to maintain hemoglobin levels between 10 g/dL and 12 g/dL during the 25 weeks of the study. The primary endpoint was change from baseline in mean hemoglobin values during the evaluation period (weeks 20 - 25). ♦ RESULTS: The mean hemoglobin value during the evaluation period was 11.3 ± 1.07 g/dL, and the mean change from baseline was 0.10 ± 1.15 g/dL (95% confidence limits: -0.24, 0.44 g/dL). During the evaluation period, most patients maintained hemoglobin levels between 10 g/dL and 12 g/dL (63.0%) and within ±1.0 g/dL of baseline (60.9%). The median weekly epoetin dose at baseline was 96.0 U/kg, and the median starting peginesatide dose was 0.047 mg/kg. Forty-three patients (72.9%) completed the study. Six patients (10.2%) received red blood cell transfusions. The observed adverse event profile was consistent with underlying conditions in the PD patient population. The most common adverse event was peritonitis (20.3%), a complication commonly associated with PD. Four deaths occurred during the study (2 related to septic shock, and 1 each to myocardial ischemia and myasthenia gravis). ♦ CONCLUSIONS: In this study, once-monthly peginesatide maintained hemoglobin levels in PD patients after conversion from epoetin.
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Authors | Raja Zabaneh, Simon D Roger, Mohamed El-Shahawy, Michael Roppolo, Grant Runyan, Janet O'Neil, Ping Qiu |
Journal | Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis
(Perit Dial Int)
2015 Jul-Aug
Vol. 35
Issue 4
Pg. 481-9
ISSN: 1718-4304 [Electronic] United States |
PMID | 24584613
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2015 International Society for Peritoneal Dialysis. |
Chemical References |
- Hemoglobins
- Peptides
- peginesatide
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Topics |
- Anemia
(drug therapy, etiology, physiopathology)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Female
- Follow-Up Studies
- Hemoglobins
(drug effects)
- Humans
- Male
- Maximum Tolerated Dose
- Peptides
(therapeutic use)
- Peritoneal Dialysis
(adverse effects, methods)
- Renal Insufficiency, Chronic
(diagnosis, therapy)
- Risk Assessment
- Severity of Illness Index
- Treatment Outcome
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