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Abstract: TH-PO1184

Results of the START-CKD Trial (Strategies Using Darbepoetin Alfa to Avoid Transfusions in CKD)

Session Information

Category: Anemia and Iron Metabolism

Authors

  • Toto, Robert D., University of Texas Southwestern Medical Center, Dallas, Texas, United States
  • Petersen, Jeffrey, Amgen, Thousand Oaks, California, United States
  • Berns, Jeffrey S., University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, United States
  • Lewis, Eldrin F., Brigham and Women's Hospital, Boston, Massachusetts, United States
  • Tran, Qui, Amgen Inc, Newbury Park, California, United States
  • Weir, Matthew R., University of Maryland School of Medicine, Baltimore, Maryland, United States
Background

Exposure to high doses of an erythropoiesis stimulating agent (ESA), high cumulative dose, wide Hb excursions, and rapid hemoglobin (Hb) rises may contribute to cardiovascular adverse events with ESA use. Thus, there is a desire to define an ESA dosing strategy that minimizes red blood cell transfusion and limits dose. The START-CKD trial evaluated such a dosing strategy using darbepoetin in anemic subjects with stage 3-5 CKD using a fixed dosing (FD) strategy of 0.45 µg/kg Q4 wks or a Hb-based titration dose (TD) algorithm (per US prescribing information (USPI).

Methods

This was a US phase 3, multicenter, randomized, double-blind, parallel group study (N=756; ClinicalTrials.gov, NCT01652872)with 377 subjects randomized to the TD and 379 to the FD treatment for up to 2 years. The primary endpoint was the percentage of subjects transfused. Transfusions, per protocol, were performed as deemed necessary by the treating physician and were prospectively adjudicated.

Results

Mean age of the subjects, baseline Hb and eGFR: 69 yrs., 9.0 g/dL and 22 ml/min/1.73m2, respectively and were balanced between arms. The % of subjects transfused was 24.1% vs 24.4% in the FD and TD groups, respectively, with similar time to first transfusion (HR 1.01, Figure A). Average Hb achieved was greater in the TD group compared to the FD group, 9.7 vs 9.4 g/dL respectively (Figure B). Average cumulative dose of darbepoetin per 4 wks was less in the FD group, 30.8 µg vs 50.7 µg.g.

Conclusion

In this study, minimizing RBC transfusion can be achieved using a low fixed-dose of darbepoetin with lower cumulative dose than use of Hb-based dose titration approach.

Figure A. Kaplan-Meier Plot of Time to First RBC Transfusion

Figure B. Hemoglobin Concentration at Each Study Visit (Mean +/- SE)

Funding

  • Commercial Support