Once-monthly dosing of Hematide safely boosted hemoglobin in non-dialysis anemic CKD patients.

BARCELONA—A novel peptide-based erythropoiesis-stimulating agent (ESA) called Hematide safely raises hemoglobin levels in anemic CKD patients and maintains stable hemoglobin levels in hemodialysis patients who switch to the drug from epoetin alfa, data suggest.


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Iain Macdougall, MD, Consultant Nephrologist and Honorary Senior Lecturer at King’s College Hospital in London, and his colleagues re-ported preliminary findings of two phase II open-label studies of the synthetic agent. One study looked at anemia correction in 89 non-dialysis CKD patients and the other was a conversion study involving 90 hemodialysis patients.


The correction study, which was led by Dr. Macdougall, included non-dialysis CKD patients naïve to ESA therapy who had baseline hemoglobin of 9.0-10.9 g/dL. Patients received either IV or subcutaneous (SC) Hematide once every four weeks for 24 weeks. The mean dose was 0.05 mg/kg at dose 1 and 0.04 mg/kg at dose 6. Dose titrations were allowed after the initial dose. Doses were increased for 5% of patients and decreased for 26% over the course of the study. The mean hemoglobin level peaked at just over 12.0 g/dL four weeks after initiation of therapy, and then declined to just under 12.0 g/dL at week 24, the researchers reported.


“A range of initial Hematide doses from 0.025 to 0.05 mg/kg is adequate to increase hemoglobin in anemic CKD patients, and IV and SC dosing appear to result in similar hemoglobin increases,” the investigators concluded. He reported findings here at the 44th Congress of the European Renal Association-European Dialysis and Transplant Association.


The conversion trial, which was conducted by investigators in the United States, involved hemodialysis patients with a stable hemoglobin level of 10.0-12.5 g/dL while on epoetin alfa. The patients were given IV Hematide every four weeks for 24 weeks. Epoetin alfa was discontinued on study entry. The mean Hematide dose was 0.08 mg/kg at dose 1, and 0.10 mg/kg at dose 6. Doses were increased for 21% of patients and decreased for 11%. The mean hemoglobin level remained stable in the conversion group over the 24 weeks of the study.


The researchers noted that hemodialysis patients require higher doses to maintain hemoglobin levels than patients not on dialysis even though mean baseline levels of hemoglobin, transferrin saturation and ferritin levels were higher in the dialysis group than in those not on dialysis, according to the investigators.


Among the patients enrolled in both studies, 6% reported 39 possible or probable drug-related adverse events (AEs). Of these, four patients had anemia or low hemoglobin, three reported fatigue, and two patients in each category reported weakness, rash, hypertension and headache. Seven patients died during the study, but none of the deaths were drug related.


Commenting on the possible advantages of Hematide, Francesco Locatelli, MD, professor of nephrology at the University of Brescia and University of Milan, noted that once-monthly dosing is an attractive feature, particularly for non-dialysis CKD patients. Moreover, Hematide is not a protein, so it may be more stable to store and less expensive to make than biological agents.


Additionally, Hematide does not appear to trigger the development of anti-erythropoietin antibodies, Dr. Locatelli said. For patients who develop antibodies to other ESA agents, Hematide may prove to be a good rescue drug.