Hematide well tolerated in CKD patients

STOCKHOLM—Clinical data showed that the anemia drug Hematide given once a month was well-tolerated and maintain hemoglobin levels between 11 and 12 g/dL for one year in patients with chronic kidney disease on and not on dialysis, according to a presentation at the 45thERA-EDTA Congress.

“The focus for Takeda and Affymax are the needs of patients, which is at the forefront of drug development,” said Dr. David Recker, senior vice president, Clinical Sciences at Takeda. “Together, we are working to bring this novel potential treatment option to patients with CKD-induced anemia and physicians who treat them.”

Takeda Global Research & Development Center Inc. and Affymax Inc.—who are partnering to develop and market Hematide—reported the 12-month data from their ongoing phase 2 trial, which is evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic kidney disease.

In addition, the companies announced the results of two other studies. One study also assessed safety and tolerability of Hematide in CKD, but only for patients already on hemodialysis and a third presentation detailed data relating to the treatment with Hematide of CKD patients with Pure Red Cell Aplasia (PRCA), a rare but serious condition, where the body produces antibodies to erythropoiesis stimulating agents (ESAs) and the patient’s endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent. In this study, treatment of these patients with Hematide resulted in maintenance of hemoglobin levels within target in the absence of transfusions.

Presentation Results

In the first study, long term safety and tolerability data were presented on 84 patients with CKD induced anemia. Patients entering this study had already received Hematide for at least 24 weeks. The study is following patients for up to 18 months where patients continue to receive Hematide on a once per month dosing schedule. The study was initially designed in 2006 to maintain hemoglobin levels between 10-13 g/dL. The protocol was later modified to target hemoglobin ranges between 10-12.5 g/dL to reflect KDOQI guidelines. Four patients (4.8 percent) had at least one adverse event considered possibly or probably related to Hematide, which included increased or elevated potassium (3.6 percent), arteriovenous fistula thrombosis (1.2 percent), and hypertension (1.2 percent). No serious adverse events were considered related to study drug.

The second presentation reported the preliminary data from an ongoing open-label, multi-centre dose finding study of the safety, pharmacodynamics, and pharmacokinetics of Hematide for the maintenance of anemia in hemodialysis patients previously treated with epoetin. Hematide administered once every four weeks either by IV injection or subcutaneously in dialysis patients was shown to maintain mean hemoglobin concentrations between 11 and 12 g/dL throughout the study. No adverse or serious adverse events were considered related to Hematide. Further assessment of intravenous and subcutaneous dosing is currently underway in a phase 3 study.

The third presentation showed the benefit of Hematide for all 10 patients with PRCA at the time of this interim analysis. The average baseline hemoglobin levels increased from 9.7g/dL (9 of 10 transfusion-dependent) prior to treatment, to an average of 11.6 g/dL by six months, with transfusion requirements eliminated in all but one patient by 6 months, and in all patients by 8 months. The four adverse events considered possibly related to Hematide were hypertension, bone pain, injection site hematoma and increased blood pressure. No Hematide-related serious adverse events were reported.

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