Anemia management in patients on peritoneal dialysis: efficacy and safety of epoetin  

Abstract

In a one-year, multicenter, open-label, uncontrolled trial, epoetin δ was given subcutaneously, 1-3-times weekly to peritoneal dialysis patients who had previously received an epoetin. Dose was adjusted to maintain hemoglobin at 10.0-12.0 g/dL. The primary endpoint was mean hemoglobin over weeks 12-24. Safety was assessed. Mean±SD baseline hemoglobin was 11.2±0.9 g/dL. Hemoglobin over weeks 12-24 was 11.6±1.1 g/dL. Adverse events were those expected in this patient population. No life-threatening adverse events occurred. Subcutaneous epoetin δ was effective and well tolerated for the treatment of anemia in peritoneal dialysis patients.

Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice (ERBP)

“…Epoetin delta has the same amino acid sequence as endogenous epoetin, and epoetin alpha and beta, but is synthesized in human cells [21], a process that may theoretically circumvent problems arising from species-dependent differences in protein folding or post-translational modifications. However, such theoretical problems have so far not become obvious and the pharmacodynamics and pharmacokinetics of epoetin delta are also similar to those of other recombinant human erythropoietins [22]; clinical trials indicate that it corrects renal anaemia in rHuEPO-naive patients [23] and can be used in the maintenance therapy of those already receiving epoetin alpha [24][25][26][27].…”

Epoetin Delta as an Antifibrotic Agent in the Remnant Kidney Rat: A Possible Role for Transforming Growth Factor Beta and Hepatocyte Growth Factor

“…Unlike the available recombinant EPOs, epoetin delta is produced in a human cell line and therefore has a human-type carbohydrate structure. Subcutaneous as well as intravenous administration of epoetin delta is effective and well-tolerated for the treatment of anemia in CKD patients requiring peritoneal dialysis or hemodialysis [26,30]. To the best of our knowledge, this is the first study in which the erythropoietic effects of different dosing regimens of epoetin delta were investigated in a rat model of CRF.…”

“…Although anti-EPO antibodies have been found in 4 animals treated 3 times a week with epoetin delta, the development of these anti-EPO antibodies did not impair the erythropoietic response, neither was it dependent on the administered dose. Taken together, this is the first experimental study showing that epoetin delta, besides its successful effects in the management of renal anemia in CKD patients [23,24,25,26], is also effective in correcting anemia in the remnant kidney rat model. In addition to its hematopoietic effects, it has been hypothesized that EPO could influence the progression of renal impairment [32].…”

“…In addition, the pharmacodynamic response to epoetin delta appeared to be as expected and no neutralizing anti-EPO antibodies were detectable in any patient in any of these studies [22]. Furthermore, clinical trials have demonstrated that epoetin delta is well-tolerated and effective in the management of renal anemia in CKD patients irrespective of dialysis status (predialysis, peritoneal dialysis, hemodialysis) or dose frequency [23,24,25,26]. …”

Peginesatide to Manage Anemia in Chronic Kidney Disease Patients on Peritoneal Dialysis

“…Peritonitis is a complication commonly associated with PD (16,17), and it is often the reason that patients switch from PD to HD (18). Studies of treatment with ESAs in patients on PD have reported peritonitis rates ranging from 9.3% to 29.4% (10,14,19).…”