Efficacy and safety of once-monthly continuous erythropoietin receptor activator in patients with chronic renal anemia.

Abstract

BACKGROUND:

In the management of anemia in patients with chronic kidney disease stage 5 undergoing dialysis (CKD-5D), maintaining hemoglobin (Hb) within the range recommended by the guidelines is challenging.

METHODS:

The CARISMA study aim was to evaluate the efficacy, safety and tolerability of a once-monthly continuous erythropoietin receptor activator (CERA) for the treatment of anemia in CKD-5D patients. In this single-arm, multicenter, open-label, phase IIIb study, we screened adult patients from 66 centers in Italy receiving intravenous epoetin alfa or beta or darbepoetin alfa. Eligible patients entered the CERA dose titration phase (DTP), followed by an efficacy evaluation period (EEP) and a long-term safety period (LTSP). Patients were analyzed by intention-to-treat (ITT), per protocol (PP) and safety populations.

RESULTS:

The rate of patients maintaining Hb within the range 10.0-12.0 g/dL throughout the EEP was 63.22% (220/348), and concentration from baseline to any postbaseline time point. CERA may thus offer a convenient and effective treatment 73.94% (122/165) in the ITT and PP population, respectively, periods in both populations. The rate of patients requiring a dose change was higher during the DTP (69.2%) and the LTSP (73.0%) than during the EEP (54.5%), as expected. CERA treatment was generally well tolerated.

CONCLUSIONS:

Once-monthly CERA administered to CKD-5D patients was associated with negligible changes in mean Hb option for these patients.

• Authors: Francesco Locatelli, Salvatore Mandolfo, Massimo Menegato Adorati, Giuseppe Villa, Renzo Tarchini, Francesco Pizzarelli, Ferruccio Conte, Carlo Guastoni, Biagio Ricciardi, Alessandro Crotta
• Journal: Journal of nephrology (J Nephrol) 2013 Nov-Dec Vol. 26 Issue 6 Pg. 1114-21 ISSN: 1724-6059 [Electronic] Italy
• PMID: 24052462 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Hematinics
• Recombinant Proteins
• continuous erythropoietin receptor activator
• epoetin beta
• Erythropoietin
• Darbepoetin alfa
• Polyethylene Glycols
• Epoetin Alfa
• Hemoglobin A

Topics

• Aged
• Anemia (blood, drug therapy, etiology)
• Darbepoetin alfa
• Drug Administration Schedule
• Epoetin Alfa
• Erythrocyte Transfusion (statistics & numerical data)
• Erythropoietin (administration & dosage, adverse effects, analogs & derivatives)
• Female
• Hematinics (administration & dosage, adverse effects)
• Hemoglobin A (metabolism)
• Humans
• Italy
• Male
• Middle Aged
• Polyethylene Glycols (administration & dosage, adverse effects)
• Recombinant Proteins (administration & dosage)
• Reference Values
• Renal Insufficiency, Chronic (blood, complications)
• Treatment Outcome