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A randomised single-blind study to improve health-related quality of life by treating anaemia of chronic kidney disease with Aranesp® (darbepoetin alfa) in older people: STIMULATE

Abstract

Background

The prevalence of chronic kidney disease (CKD) increases with age, and the risk of significant anaemia increases as renal function declines. The objectives of this study were to assess the effect of darbepoetin alfa administration on health-related quality of life (HRQOL) through treatment for anaemia in older patients with CKD.

Methods

In this multicentre, randomised, placebo-controlled trial, older patients (aged ≥70 years) with CKD (Stages 3–5, predialysis) and haemoglobin (Hb) < 11.0 g/dL were randomised to darbepoetin alfa (n = 28) or placebo (n = 23). HRQOL was measured using a number of instruments including Short Form-36 (SF-36) and Functional Assessment of Cancer Therapy-Anaemia (FACT-An).

Results

The primary endpoint, mean SF-36 Vitality Score at Week 24, was comparable between the darbepoetin alfa (51.4 [95 % CI 48.0, 54.9]) and placebo (46.7 [40.9, 52.5]) groups. Darbepoetin alfa-treated patients experienced statistically significant improvements in some SF-36 and FACT-An Subscale Scores. Mean Hb was higher with darbepoetin alfa (12.5 [12.1, 12.9] g/dL) than with placebo (10.5 [10.1, 11.0] g/dL). The safety profiles were comparable between the treatment groups. The study was limited by only 20 % of the planned patient recruitment being achieved.

Conclusions

Darbepoetin alfa increased Hb and, within study limitations, suggested that improvements in some HRQOL domains in older CKD patients with anaemia may be achieved with more physiological haemoglobin.

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Acknowledgments

The authors wish to thank the participating dialysis centres and investigators for contributions to the study and data collection—Drs Stephen Chow, Serge Cournoyer, Robert Fassett, Margaret Fraenkel, Marc Ghannoum, Helen Healy, Ashley Irish, Garth Mortis, Danny Sapir and Andrew Steele. This study was funded and sponsored by Amgen Australia Pty Ltd and Amgen Canada Inc. Data analysis was performed by Dave Carter, Nicola Hogan and Julie-Ann Quayle. Editorial assistance was provided by Yoonah Choi of Evidencia Medical Communications Pty Ltd, contracted by Amgen Australia Pty Ltd.

Conflict of interest

S.D.R. has received research funding from Amgen, Janssen-Cilag, La Hoffman Roche and Affymax. S.V.J. has received research funding from Ortho Biotech and speaker honoraria from Amgen, Ortho Biotech and Pfizer. S.D.S. has received research funding from Amgen, Roche and Merck. M.C.W. has no conflicts of interest relevant to this article. L.P.M. has accepted research grants from Amgen.

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Correspondence to Simon D. Roger.

Additional information

This study was conducted on behalf of the STIMULATE study group.

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Roger, S.D., Jassal, S.V., Woodward, M.C. et al. A randomised single-blind study to improve health-related quality of life by treating anaemia of chronic kidney disease with Aranesp® (darbepoetin alfa) in older people: STIMULATE. Int Urol Nephrol 46, 469–475 (2014). https://doi.org/10.1007/s11255-013-0512-1

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Keywords

  • Anaemia
  • Quality of life
  • Erythropoiesis-stimulating agents
  • Chronic kidney disease