Data from Phase 2 clinical trials of Hematide/peginesatide presented at NKF Annual Meeting

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Affymax, Inc. (Nasdaq: AFFY) and Takeda Global Research & Development Center, Inc., U.S., today announced data from several post hoc analyses of Phase 2 clinical trials that evaluated Hematide/peginesatide in dialysis patients with anemia in chronic kidney disease (CKD). The data provide hypotheses for further investigation of this agent in anemia management in this patient population. The findings were presented in three separate posters at the National Kidney Foundation (NKF) Annual Meeting being held in Orlando, Florida.

“Hemoglobin Cycling in Hemodialysis Patients Treated With Recombinant Human Erythropoietin.”

According to the U.S.-approved labels for erythropoiesis stimulating agents (ESAs), it is recommended that hemoglobin (Hb) levels be maintained within ranges of 10-12 grams per deciliter (g/dL) in patients with renal disease or chronic renal failure (CRF). However, there may be difficulties achieving this goal, including Hb fluctuations below or above recommended ranges (Hb variability or cycling), the need for frequent dose adjustments or elevated doses to keep poor ESA responders within range, and other potential concerns. Another treatment challenge is maintaining Hb levels in dialysis patients who have been hospitalized.

"The reality of managing anemia with ESAs in CRF patients presents certain challenges," said Anne-Marie Duliege, M.D., chief medical officer at Affymax. "Randomized, controlled, comparative Phase 3 studies of Hematide are ongoing, which will provide additional information in this population."

"These Phase 2 analyses reinforce the importance of evaluating issues that affect this fragile patient population," said Ali Hariri, M.D., medical director, Takeda. "Our goal with Hematide is to provide physicians with a convenient alternative treatment option to help manage anemia in people with chronic renal failure."

Analysis of Hemoglobin Stability with Hematide/peginesatide in Hemodialysis Patients (Poster #217) - 14, April 2010

Based on data from 62 dialysis patients enrolled in one of the open-label Phase 2 extension studies, Hematide, administered once every four weeks, appeared to keep patients within Hb target ranges, with relatively stable mean Hb levels maintained over time. Based on Hb levels over a six month period, Hb cycling, as defined by two consecutive Hb excursions (a change in monthly Hb level ≥ 1.5 g/dL) in different directions, was observed in 8.6 percent of patients treated with Hematide.

Epoetin Alfa and Hematide/peginesatide Requirements Differ in Erythropoiesis-Stimulating Agent Hyporesponsive Hemodialysis Patients (Poster #63) - 14, April 2010

A post hoc analysis of the data from 145 dialysis patients enrolled in two open-label Phase 2 studies examined the response to Hematide treatment in patients directly switched from epoetin alfa given three times a week. Hematide doses were titrated over a five-to-six month period to maintain target Hb concentrations. Patients who received ≥ six doses of Hematide>

Evaluation of the Maintenance of Hemoglobin Control in Hemodialysis Patients Both During and After Hospitalization with Once-Monthly Hematide/peginesatide (Poster #163) - 14, April 2010

Another post hoc analysis in 47 dialysis patients from the two open-label Phase 2 extension studies, treated with Hematide once every four weeks, was performed to evaluate the changes in Hb levels pre- to post-hospitalization, as well as the amount of time and Hematide dose to recover to pre-hospitalization Hb levels. The average (mean) Hb levels for Hematide patients were 11.1 g/dL before hospitalization and 10.8 g/dL immediately post-hospitalization. Hb values at one and two months following hospitalization were 10.9 g/dL and 11.2 g/dL respectively. In addition, the mean change in pre- to post-hospitalization dose requirements was minimal (5-10%) during the two months post-hospitalization and back to baseline thereafter.

Across the studies that were the basis of these three posters, serious adverse events that were considered possibly related to Hematide treatment by study investigators included an infusion-site reaction and a patient who developed a fatal pulmonary embolism. The most common adverse events included upper respiratory tract infection, arteriovenous fistula site complication, dyspnea, diarrhea, muscle spasms, headache, nausea and vomiting. None of the patients developed Hematide-specific antibodies.

In addition, three other posters entitled "Long-Term Clinical Experience with Hematide/peginesatide" (poster #161), "Hemoglobin Decline Following Hematide/peginesatide Dose Interruption (poster #43)" and "Hematide/peginesatide Dose Adjustments in the Maintenance of Hemoglobin in Hemodialysis Patients (poster #240)" were presented at the meeting.

The clinical significance of all these post hoc analyses are unknown and warrant further investigation. Phase 3 studies are ongoing.

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