1. 1. The STRATA Study

2. Kidney Transplant 1. The STRATA Study (Study of Transplant-Related Anemia Treated with Aranesp) Source Bloom RD, Bolin P, Gandra SR, et al. Impact on health-related quality of life in kidney transplant recipients with late posttransplant anemia administered darbepoetin alfa: results from the STRATA study. Transplant Proc. 2011;43(5):1593–1600.

3. Background In patients with end-stage renal disease, anemia is a common complication. In most cases, anemia improves after renal transplantation, usually within the first 3 months. Post-transplant anemia is, however, highly prevalent (30–40%). Anemia is believed to have a substantial negative impact on the health-related quality of life (HRQOL) and includes lethargy and sleep disturbance. Darbepoetin alfa (Aranesp, Amgen Inc, Thousand Oaks, CA, USA) is an ESA with the same mechanism of action as recombinant human erythropoietin but has a longer half-life as well as greater biological activity.

4. Aim To assess the effect of darbepoetin alfa administered subcutaneously on hemoglobin and HRQOL.

5. Methods

7. Summary of key results Increase in mean hemoglobin concentration from 9.9 (1.2) g/dL at baseline to 11.7 (1.3) g/dL during the evaluation period. Significant improvement in physical component summary (PCS), physical functioning, limitations due to physical health, bodily pain, limitations due to emotion health, and vitality scores seen with darbepoetin alfa use. SF-36 sub-scales and component summary scores were lower in subjects with baseline Hb <10 g/dL than in subjects with Hb ≥10 g/dL. Statistically significant improvement observed for all subjects in physical component summary (0.5 points, P<0.001), physical functioning (11.8 points, P=0.001), limitations due to physical health (26.5 points, P<0.001), bodily pain (7.7 points, P=0.01), limitations due to emotional health (15.7 points, P=0.01), and vitality (12.8 points, P<0.001) from baseline to week 24 following treatment with darbepoetin alfa.

9. Conclusion This study indicates that the patients with post-transplant anemia have lower HRQOL than the general population. Improvement in HRQOL and levels of hemoglobin was seen with treatment with darbepoetin alfa. In patients undergoing kidney transplant with PTA, darbepoetin alfa significantly increased Hb concentrations and improved HRQOL scores.